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Transcatheter mitral edge-to-edge repair (TEER) with transcatheter devices has become a mainstay in the minimally invasive treatment of patients with severe mitral regurgitation at increased surgical risk. Despite its apparently favorable risk profile, there is uncertainty on the risk and features of cerebrovascular accidents (CVAs) early and long after transcatheter mitral valve repair. We aimed to appraise the incidence and predictors of CVA in patients who underwent TEER. We explicitly queried the data set of an ongoing multicenter prospective observational study dedicated to TEER with MitraClip (Abbott Vascular, Santa Clara, California). The incidence of CVAs after TEER was formally appraised, and we explored potential predictors of such events. Descriptive, bivariate, and diagnostic accuracy analyses were performed. Of 2,238 patients who underwent TEER, CVAs occurred in 33 patients (1.47% [95% confidence interval 1.02% to 2.06%]), including 6 (0.27% [0.10% to 0.58%]) in-hospital strokes and 27 events after discharge (0.99% [0.66% to 1.44%]), over a median follow-up of 14 months. Most CVAs were major ischemic strokes during and after the in-hospital phase. Overall, CVAs were more common in patients with atrial fibrillation (p = 0.018), renal dysfunction (p = 0.032), higher EuroSCORE II (p = 0.033), and, as expected, higher CHA2DS2-VASc score (p = 0.033), despite the limited prognostic accuracy of the score. Notably, the occurrence of CVA did not confer a significantly increased risk of long-term (p = 0.136) or cardiac death (p = 0.397). The incidence of CVA in patients who underwent TEER is low, with most events occurring after discharge and being associated with preexisting risk features. These findings, although reassuring on the safety of TEER, call for proactive antithrombotic therapy whenever CVA risk is increased before and after TEER., Competing Interests: Declaration of competing interest Dr. Adamo has received speaker fees from speaker fees from Abbott Structural Heart. Giuseppe Biondi-Zoccai has consulted for aleph, Amarin, Balmed, Cardionovum, Crannmedical, Endocore Lab, Eukon, Guidotti, Innovheart, Meditrial, Menarini, MicroPort, Opsens Medical, Terumo, and Translumina outside the present work. The remaining authors have no competing interests to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: Transcatheter edge-to-edge repair (TEER) has become an established minimally invasive treatment for significant mitral regurgitation. Ongoing refinements and the availability of different clipping devices have expanded the indications for and effectiveness of TEER, but comprehensive comparative data on this issue are lacking. In this study, we compared NT, NTr, and XTr MitraClip devices (Abbot) for TEER., Methods: Details on patient, imaging, and procedural details, as well as short- and long-term outcomes, were sought from a national prospective clinical registry on TEER with MitraClip. The primary outcome of interest was discharge after procedural success without major clinical complications., Results: A total of 2236 patients were included, 1228 (54.9%) in whom NT implantation only was attempted, 233 (10.4%) in whom NTr but not XTr implantation was attempted, and 775 (34.7%) in whom XTr implantation was attempted. Clinical and imaging features differed substantially across the groups, reflecting expanding indications with NTr and XTr devices. In-hospital outcomes were largely similar among the 3 groups, including death. Long-term unadjusted estimates of effect showed significant differences in several outcomes, including death, rehospitalization, and their composite, which demonstrated that NT was associated with more unfavorable outcomes compared with the other devices (all P less than .05). However, most differences depended on baseline features, as adjusted analysis showed no significant differences for early as well as long-term outcomes, including long-term death, rehospitalization, and their composite (all P greater than .05)., Conclusions: New-generation MitraClip devices are associated with favorable procedural and clinical outcomes, despite being used in patients with more adverse features, when compared with patients treated with previous devices.

Background: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication., Objectives: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry., Methods: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes., Results: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients., Conclusions: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful., Condensed Abstract: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high., Competing Interests: Declaration of competing interest A. Aminian is a consultant and proctor for Boston Scientific and Abbott. I. Akin received lecture and proctoring fees from Boston Scientific for the Watchman Okkluder. J. Lund discloses a clinical advisor (proctor) role in LAAC (Abbott) and lecture fees (Abbott, Boston scientific). E. Guerios serves as proctor for LAA closure for Abbott and Lifetech Scientific. N. Amabile has received proctoring and consulting fees from Abbott Vascular and Boston Scientific. C. Skurk has received proctor honoraria from Boston Scientific and speaker fees from Boston Scientific and Lifetech Scientific. J. Harvey is proctor for Abiomed, Boston Scientific and Medtronic and part of the Speaker's bureau for Abiomed, Boston Scientific and Medtronic. He also is part of the advisory board for Avail, Boston Scientific and Medtronic. H. Sievert has received study honoraria to institution, travel expenses and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, Celonova, Contego, Coramaze, Croivalve, CSL Behring LLC, CVRx, Dinova, Edwards, Endobar, Endologix, Endomatic, Esperion Therapeutics, Inc., Hangzhou Nuomao Medtech, Holistick Medical, Intershunt, Intervene, K2, Laminar, Lifetech, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronic, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed and Whiteswell. M. Kühne received personal fees from Bayer, Böhringer Ingelheim, Pfizer BMS, Daiichi Sankyo, Medtronic, Biotronik, Boston Scientific, Johnson & Johnson, and F. Hoffmann-La Roche Ltd., as well as grants from Bayer, Pfizer, Boston Scientific, BMS, Biotronik, and Daiichi Sankyo. S. Sabir is part of the Boston Scientific WATCHMAN advisory board. J. Kim has received proctoring fees from Abbott Vascular. M. Montorfano received consultant fees from Abbott, Boston Scientific, Kardia. M. Ancona received consultant fees from Abbott. Relevant research funding went to Vanderbilt University Medical Center from Boston Scientific, Boehringer-Ingelheim, Medtronic and Atricure, where C. Ellis is practicing. He also reseves a consultant and advisor fee from Abbott Medical, Atricure, Boston Scientific, Medtronic. L. Nombela-Franco is proctor for Abbott Vascular and has received lectures fees from Boston Scientific. A. Natale has received speaker honoraria from Boston Scientific, Biosense Webster, St. Jude Medical, Biotronik, and Medtronic. He also is a consultant for Biosense Webster, St. Jude Medical, and Janssen. All other authors declare that they have no competing interests., (Copyright © 2024. Published by Elsevier Inc.)

Background: Minimally invasive mitral valve repair has a favorable risk-benefit profile in patients with significant de novo mitral regurgitation. Its role in patients with prior mitral valve repair is uncertain. We aimed to appraise the outcome of patients undergoing transcatheter edge-to-edge repair (TEER) with prior transcatheter or surgical mitral valve repair (SMVR)., Methods and Results: We queried the Italian multicenter registry on TEER with MitraClip, distinguishing naïve patients from those with prior TEER or (SMVR). Inhospital and long-term clinical/echocardiographic outcomes were appraised. The primary outcome was the occurrence of death or rehospitalization for heart failure. A total of 2238 patients were included, with 2169 (96.9%) who were naïve to any mitral intervention, 29 (1.3%) with prior TEER, and 40 (1.8%) with prior SMVR. Several significant differences were found in baseline clinical and imaging features. Respectively, device success was obtained in 2120 (97.7%), 28 (96.6%), and 38 (95.0%, P =0.261) patients; procedural success in 2080 (95.9%), 25 (86.2%), and 38 (95.0%; P =0.047); and inhospital death in 61 (2.8%), 1 (3.5%), and no ( P =0.558) patients. Clinical follow-up after a mean of 14 months showed similar rates of death, cardiac death, rehospitalization, rehospitalization for heart failure, and their composite (all P >0.05). Propensity score-adjusted analysis confirmed unadjusted analysis, with lower procedural success for the prior TEER group (odds ratio, 0.28 [95% CI, 0.09-0.81]; P =0.019) but similar odds ratios and hazard ratios for all other outcomes in the naïve, TEER, and SMVR groups (all P >0.05)., Conclusions: In carefully selected patients, TEER can be performed using the MitraClip device even after prior TEER or SMVR.

Concomitant severe mitral-tricuspid regurgitation is observed in up to 30% of patients with reduced left ventricular ejection fraction. In symptomatic subjects at high surgical risk, transcatheter treatment is a viable option in the presence of suitable anatomy. We present a case of mitral regurgitation worsening after TriClip (Abbott, Abbott Park, IL) implantation in a patient with a previous successful MitraClip (Abbott) intervention. The correction of tricuspid regurgitation by catheter repair improves overall hemodynamics, but it can sometimes paradoxically worsen mitral regurgitation, as herein displayed. Clinical care is needed to detect tricuspid regurgitation repair-induced worsening of mitral regurgitation and ensure optimal management., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Coronary sinus (CS) Reducer implantation improves myocardial perfusion and symptoms in patients with debilitating refractory angina. Its impact on myocardial remodeling remain uncertain. Aim of the present study was to assess possible impact of CS Reducer on myocardial systolic-diastolic deformation and microstructural remodeling, as assessed through cardiac magnetic resonance (CMR) feature tracking and mapping analysis. Twenty-eight consecutive patients with refractory angina underwent multiparametric stress CMR before and 4 months after CS Reducer implantation. Eight patients were excluded (6 for absence of inducible ischemia, 2 for artifacts). Modifications in 3D systo-diastolic myocardial deformation were evaluated using feature tracking analysis on rest cine images. Myocardial microstructural remodeling was assessed by native T1 mapping, cellular and matrix volume and extracellular volume fraction (ECV). Collaterally, the percentage of ischemic myocardium (ischemic burden %) and the myocardial perfusion reserve index (MPRI) were measured. After CS Reducer implantation, myocardial contractility improved (ejection fraction rose from 61 to 67%; p = 0.0079), along with longitudinal (from - 16 to - 19%; p = 0.0192) and circumferential strain (from - 18 to - 21%; p = 0.0017). Peak diastolic radial, circumferential and longitudinal strain rate did not change (p > 0.05), and no changes in native T1, ECV, cellular and matrix volume were observed. Myocardial perfusion improved, with a reduction of ischemic burden (13-11%; p = 0.0135), and recovery of intramural perfusion balance in segments with baseline ischemia (MPRi endocardial/epicardial ratio from 0.67 to 0.96; p = 0.0107). CS Reducer improves myocardial longitudinal and circumferential strain, without microstructural remodeling and no impact on diastolic proprieties.

Objectives: To evaluate the impact of coronary sinus (CS) Reducer implantation upon left ventricular (LV) function., Background: CS Reducer implantation is associated with symptomatic relief in patients with refractory angina. The effects of the device upon left ventricular function remains unknown., Methods: Prior to device implantation and at 4-months, resting ventricular volumes and function were measured using cardiac magnetic resonance (CMR). Stress CMR was performed to extract quantitative indices of myocardial perfusion (myocardial perfusion reserve index-MPRI)., Results: Nineteen patients (18 males, 66.0 [IQR 56.0-77.0] years), underwent successful Reducer implantation. Sixteen (84%) patients improved by at least 1 CCS class. Four months after Reducer implantation, we noticed a significant improvement in LV ejection fraction (LVEF) (61 [IQR 47-71] to 66 [IQR 57-72] %; p = .009), a reduction in LV end-diastolic volume (LVEDV)/Body surface area (BSA) (65.7 [IQR 57.4-89.6] to 64.7 [IQR 53.7-74.1] mL/m 2 ; p = .036) and a reduction in LV end-systolic volume (LVESV)/BSA (28.7 [IQR 18.6-38.8] to 20.0 [IQR 15.0-31.4] mL/m 2 ; p = .007). Patients with reduced EF (EF < 50%, n = 6) presented a greater increase of EF at follow up compared to patients with preserved EF (11.3 [IQR 6.5-54.5] vs. 3.8 [IQR 0.6-9.1] %; p = .029). The observed decrease in LVESV/BSA was greater in patients with reduced EF (23.6 [IQR 11.6-33.8] vs. 4.2 [IQR -2.0 to 8.4] mL/m 2 ; p = .005). A significant increase in transmural MPRI was observed 4 months after Reducer implantation (p < .011)., Conclusions: CS Reducer improved angina symptoms and improved left ventricular function. The improvement was pronounced in the subgroup of patients with reduced ejection fraction. Myocardial perfusion improvement could represent the underlying mechanism for the observed benefits., (© 2019 Wiley Periodicals, Inc.)

Transcatheter tricuspid valve intervention is gaining importance due to the development of percutaneous techniques addressing tricuspid regurgitation. The presence of a redundant eustachian valve can increase procedural complexity by restricting the manipulation of transcatheter devices. We present a case of torrential tricuspid regurgitation and a redundant eustachian valve hampering the manipulation of the delivery system. We were able to reach the tricuspid valve by looping 2 standard guidewires into the atrium. We performed a tricuspid-plasty by implanting 2 MitraClips with a satisfactory final result. This technique can be applied when the eustachian valve impairs navigation in the right atrium., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Severe mitral regurgitation (MR) is fairly common in the general population and is associated with significant morbidity and mortality. Although surgical mitral valve (MV) repair and replacement are well established treatment options for MV disease, as much as one-half of patients with severe, symptomatic MR are not referred for surgery due to prohibitive procedural risk. Novel transcatheter alternatives are therefore being developed to provide an alternative treatment for these patients. A growing experience with transcatheter MV replacement (TMVR) strategies is accumulating and promising early results have been reported. However, the risk of transcatheter heart valve (THV) thrombosis seems to be relevant after TMVR, potentially higher than that observed after transcatheter aortic valve replacement, and routine anticoagulant therapy appears to be necessary to mitigate this risk. Hereafter, the authors: 1) review available evidence on thrombotic risk after TMVR (including new dedicated THVs for native MV, valve-in-valve, valve-in-ring, and valve-in-mitral annular calcification); and 2) discuss the antithrombotic treatment strategies after TMVR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Microcatheter derived fractional flow reserve (FFR MC ) system has an increased profile compared with pressure-wire derived fractional flow reserve (FFR W ). Consequently, the FFR MC system itself may increase the degree of coronary artery stenosis and lower the measured FFR value. This can affect the diagnostic accuracy of the FFR MC system and inadvertently result in erroneous therapy for patients. Our aim was to evaluate the diagnostic accuracy FFR MC measurements and provide a means for clinicians to interpret individual FFR MC results with respect to FFR W . Correlation between FFR measurement techniques was analyzed in this lesion level analysis of 413 patients and 441 lesions from 6 studies. The reference standard to determine physiological significant stenosis was FFR W value ≤0.80. The mean values for FFR MC and FFR W were 0.80 ± 0.11 and 0.83 ± 0.09, respectively. Bland-Altman analysis demonstrated a bias toward overestimation of FFR by FFR MC (bias, -0.03 [0.05]). The overall lesion level diagnostic accuracy of the FFR MC system was 80.4% (95% confidence interval [CI] 76.2% to 84.0%). The diagnostic accuracy for FFR MC values <0.75, 0.75 to 0.85 and >0.85 were 83.7% (95% CI 71.4% to 92.4%), 72.3% (95% CI 59.8% to 75.6%), and 99.2% (95% CI 94.8% to 99.8%), respectively. Using the FFR W threshold of ≤0.80, 16.3% of lesions would have had inappropriate revascularization according to FFR MC measurements. Receiver-operating characteristics suggested the optimal cut-off value of FFR MC to determine ischemia was 0.78. In conclusion, the diagnostic accuracy of FFR MC varies markedly across the spectrum of disease with marked deterioration for values between 0.75 and 0.85. This may result in clinicians to inadvertently revascularize patients with FFR measurements >0.80., (Copyright © 2019. Published by Elsevier Inc.)

Objective: To investigate the effect of left atrial appendage (LAA) occlusion device positioning upon periprocedural and long-term outcomes., Background: The Amulet device is designed to cover the ostium of the LAA. Prolapse of the device into the neck of the LAA is not uncommon resulting in incomplete coverage of the ostium. The clinical consequences of this remain uncertain., Methods: Outcomes of 87 patients with successful LAA closure were analyzed according to Amulet disc position: group A (n = 45) had complete LAA ostium coverage; group B (n = 42) had incomplete ostium coverage because of disc prolapse. Periprocedural major adverse events (MAE) (composite of all cause death, tamponade, device/air embolization, cerebrovascular events, myocardial infarction, and major bleeding not related to vascular access complications) and total device-related periprocedural adverse events (defined as MAE and pericardial effusion) were evaluated. All patients were followed up longitudinally with long-term events defined as a composite of: cardiovascular death, cerebrovascular events, systemic embolization, and major bleeding requiring transfusion or intervention., Results: Median follow-up was 234 days (IQR 150-436 days). There was a trend toward more periprocedural MAE in group B (P = 0.07) with deep implantation of the Amulet device associated with significantly more periprocedural adverse events (P = 0.03). There were no differences in reposition attempts (P = 0.9) or long-term events (P = 0.57)., Conclusions: Our data suggest that suboptimal device positioning may be associated with worse periprocedural outcomes but no difference in long-term clinical outcomes. The results of this relatively small cohort does not seem to be affected by repositioning attempts during the index procedure., (© 2018 Wiley Periodicals, Inc.)

As new transcatheter mitral valve (MV) interventions continuously evolve, potential procedure-related adverse events demand careful investigation. The risk of cerebral embolic damage is ubiquitous in any left-sided structural heart intervention (and potentially linked to long-term neurocognitive sequelae); therefore, efforts to evaluate these aspects in the field of catheter-based MV procedures are justified. Given the peculiarities of MV anatomy, MV disease, and MV procedures, the lessons learned from other transcatheter heart interventions (i.e., transcatheter aortic valve replacement) cannot be directly translated to MV applications. Through a systematic assessment of available evidence, the authors present and discuss procedure- and patient-related factors potentially associated with cerebral embolic risk during catheter-based MV interventions. Given the paucity of available data in this field, future large, dedicated studies are needed to understand whether cerebral embolic injury represents a real clinical issue during MV procedures., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) intermittently increases the pressure in the cardiac venous outflow tract using a balloon-tipped catheter introduced percutaneously into the coronary sinus. It aims to improve microvascular perfusion in STEMI patients during PCI, thus improving infarct healing. Its successful administration was associated with an improvement in myocardial recovery four months after primary-PCI as compared to control. However, it has never been used in other settings or for a prolonged period. The aim of this study was to report on the feasibility and efficacy of prolonged PICSO to treat refractory LV dysfunction and ischemia., Methods and Results: Two patients with refractory LV dysfunction and ongoing ischemia with patent epicardial coronary artery and suspected underlying microvascular dysfunction were treated with prolonged off-label PICSO utilization. A medium of 23,990mmHg PICSO quantity (a marker of PICSO therapy performance) was achieved: it was almost fifty times the PICSO quantity previously reported in in short-term PICSO utilization. After PICSO placement, both patients showed significant improvement of myocardial ischemia and recovery of LV systolic function., Conclusion: Prolonged PICSO utilization was feasible and effective in two patients. These cases highlight a novel application of PICSO technology: redistribution of venous blood and improvement in microvascular perfusion that might be a new target in cases of refractory LV dysfunction and ongoing ischemia in the setting of patent epicardial coronary arteries., (Copyright © 2017 Elsevier B.V. All rights reserved.)

The introduction of bare-metal stents (BMS) has represented a major advancement over plain old balloon angioplasty in the management of coronary artery disease. However, the high rates of target lesion revascularization associated with use of BMS have led to the development of drug-eluting stents, which require prolonged dual antiplatelet therapy due to the increased risk of late and very late stent thrombosis. The improvements in newer-generation drug-eluting stents have translated into better safety and efficacy compared with earlier generation and BMS, thus allowing shorter dual antiplatelet therapy duration. Here, we aim to provide reasons as to why we still need BMS in our cardiac catheterization laboratory., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Percutaneous left atrial appendage (LAA) closure is currently utilized for the prophylaxis of thromboembolic cerebrovascular accidents in patients with non-valvular atrial fibrillation. The presence of LAA thrombus is usually considered a contraindication for the procedure, since there is a high risk of thrombus embolization. While reports in the literature have shown the feasibility of LAA closure in the presence of LAA thrombus with certain cerebral embolic protection devices, we present the first-in-man LAA closure of a patient with LAA thrombus using the TriGuard Embolic Protection Device.

Objectives: To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population., Background: Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared., Methods: We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed., Results: One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ≥1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices., Conclusions: Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

An 84-year-old man with cardial senile amyloidosis and severe tricuspid regurgitation was referred for right sided heart failure symptoms. The patient was scheduled for a percutaneous treatment due to the prohibitive risk of surgery. Two MitraClips were implanted using a transjugular approach with successful echocardiographic and clinical results. This case shows the rational of the procedural with a bicuspidalization of the valve demonstrated at the three dimensional transesophageal echocardiography.

Objectives: To report procedural and 30-day outcomes following percutaneous transcatheter valve-in-valve (VIV) implantation for tricuspid bioprosthesis failure, with a new generation balloon-expandable transcatheter aortic valve implantation prosthesis., Background: Severe tricuspid regurgitation is associated with a reduction in survival and increased morbidity. Many patients previously treated with tricuspid valve replacement require further intervention due to bioprosthesis failure. Surgical redo is the "gold standard" treatment however this is technically challenging and associated with significant risk. Percutaneous VIV intervention that is now well established in the management of aortic and mitral bioprosthesis failure may therefore be an alternative treatment option., Methods: The study population consisted of all patients that underwent percutaneous transcatheter tricuspid VIV implantation for tricuspid bioprosthesis failure at the San Raffaele Scientific Institute, Milan, Italy., Results: Five patients underwent successful transfemoral transcatheter tricuspid VIV implantation for bioprosthetic failure. One patient suffered acute kidney injury that was successfully medically managed. The remaining patients suffered no complications prior to hospital discharge. During 30-day follow-up, all patients reported a significant improvement in their functional status with normal valve function. Additionally, we observed an improvement in renal function (eGFR baseline 62.0 ± 16.5 vs. follow-up 70.2 ± 23.1 ml/min/m 2 , P = 0.12) and improved hepatic congestion: bilirubin (1.47 ± 0.8 vs. 1.01 ± 0.7 mg/DL, P = 0.12), alanine aminotransferase (31.0 ± 11.1 vs. 23.2 ± 5.1 U/L, P = 0.11) and aspartate aminotransferase (35.8 ± 6.3 vs. 29.8 ± 13.6 U/L, P = 0.12)., Conclusions: Transfemoral, transcatheter VIV treatment with a new generation balloon expandable devices appears to be a safe and efficacious treatment option for tricuspid bioprosthesis failure. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Data on transcatheter aortic valve implantation (TAVI) for severe bicuspid aortic valve (BAV) stenosis and how this compares to that for tricuspid aortic valve (TAV) stenosis are limited. Twenty-one consecutive patients with BAV were treated with the Edwards or CoreValve bioprosthesis from November 2007 to December 2012 at San Raffaele Scientific Institute and Clinical Institute S. Ambrogio, Milan, Italy. Results were compared with a cohort of patients with TAV (n=447) treated with the same bioprostheses over the same period. Procedural 1- and 12-month outcomes were examined as defined by the Valve Academic Research Consortium criteria. Patients with BAV were younger (76.7±7.1 vs 79.8±7.4 years, p=0.06) and with a larger aortic annulus (25.0±1.8 vs 23.6±2.1 mm, p=0.01). Device success (85.7% vs 94.4%, p=0.10) was lower in patients with BAV. Although the 30-day composite safety end point (23.8% vs 21.0%, p=0.76) was similar between the 2 groups, mortality rate at 30 days was higher (14.2% vs 3.6%, p=0.02) in the BAV group. Cardiovascular mortality at 1 year did not differ significantly between the 2 groups (10.5% vs 7.4%, p=0.62). In conclusion, transcatheter aortic valve implantation in high surgical risk patients with severe BAV stenosis appears to be feasible with mid-term cardiovascular mortality similar to that for patients with TAV. Early survival and device success, however, were lower for patients with BAV demonstrating that further studies are required to identify which subset of patients with BAV is best suited for transcatheter treatment., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the impact of baseline activated clotting time (ACT)-guided heparin administration on major bleeding after transfemoral transcatheter aortic valve implantation (TAVI)., Background: Bleeding after TAVI is frequent and associated with unfavorable prognosis. Proper intraprocedural heparin dose administration may reduce the risk of potential overdosing in this frail study group., Methods: Of the patients who underwent transfemoral TAVI in our center from November 1, 2007 to June 31, 2012, 362 were retrospectively analyzed. Because abnormally high baseline ACT values were noted, heparin was administered at the operator's discretion, according to baseline ACT (ACT-guided, n = 174) or patient's body weight (non-ACT-guided, n = 188). The primary study objective was 30-day major bleeding as defined by the Valve Academic Research Consortium criteria. Secondary objectives were any life-threatening, and minor bleeding, and other Valve Academic Research Consortium outcomes at 30 days., Results: Bleeding occurred in 167 (46.1%) patients; of these, 76 (21.0%) had major bleeding. The ACT-guided group had a significantly lower occurrence of major (7.5% vs. 33.5%, p < 0.001), life-threatening (12.1% vs. 20.2%, p = 0.04), and any bleeding (25.9% vs. 64.9%, p < 0.001). Conversely, no differences were noted in the other study objectives. After adjustment for potential confounders, the protective odds ratio for ACT-guided therapy on major bleeding was 6.4 (95% confidence interval: 2.3 to 17.9; p < 0.001) at 30 days., Conclusions: In our experience, heparin administration according to baseline ACT was correlated with a significantly lower occurrence of major bleeding in transfemoral TAVI. This strategy might be a useful tool in reducing bleeding in this high-risk study group., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Patients who undergo transcatheter aortic valve implantation are generally discharged on dual-antiplatelet therapy. However, many of these patients also have indications for anticoagulant therapy, and it is unclear what the best antithrombotic strategy is in these cases. Data from 360 patients who underwent transcatheter aortic valve implantation were retrospectively analyzed, of whom 60 (16.7%) had indications for anticoagulant treatment, mainly because of atrial fibrillation. The antithrombotic regimen was decided according to clinical evaluation of thrombotic and hemorrhagic risk; most of these patients (n = 43) were discharged with warfarin plus a single antiplatelet drug. Their outcomes were compared to those in a group with no indications for anticoagulation (n = 300) treated with dual-antiplatelet therapy. During the follow-up period (median 11 months), 53 patients (15%) died; mortality was not associated with antithrombotic regimen. The incidence of cerebral events or intracranial hemorrhage (4.6% and 1.1%, respectively) was low in the study population, and no significant differences were detected between groups; the bleeding rate was also unaffected by antithrombotic therapy. In conclusion, when anticoagulation is indicated after transcatheter aortic valve implantation, many variables must be taken into account. The most frequent scenario in this study was patients in atrial fibrillation, most of whom were discharged with warfarin plus a single antiplatelet medication. When bleeding was a concern, especially in the absence of coronary disease, warfarin alone was prescribed. These results suggest that this approach is safe, but data from larger, randomized studies are needed., (Copyright © 2013 Elsevier Inc. All rights reserved.)