Search

Background: Coronary obstruction (CO) is a potentially life-threatening complication of transcatheter aortic valve replacement (TAVR). Chimney stenting or leaflet laceration with transcatheter electrosurgery (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) are 2 techniques developed to prevent CO., Objectives: The aim of the present study was to compare periprocedural and 1-year outcomes of chimney and BASILICA in TAVR patients at high risk of CO., Methods: This multicenter observational registry enrolled consecutive TAVR patients at high risk of CO, undergoing either preventive chimney stenting or BASILICA. Clinical success was defined as successful performance of the chimney or BASILICA technique without clinically relevant ostial CO. The primary endpoint was major adverse cardiovascular events, a composite of death, myocardial infarction, stroke, or unplanned target lesion coronary revascularization at 1 year., Results: A total of 168 patients were included: 71 (42.3%) received chimney stenting, and 97 (57.7%) underwent BASILICA. Patients undergoing BASILICA had higher preprocedural risk of CO, as indicated by lower sinotubular junction height (18.2 ± 4.8 mm vs 14.8 ± 3.4 mm; P < 0.001) and diameter (28.2 ± 4.5 vs 26.8 ± 3.4; P = 0.029). Rates of periprocedural complications were similar between the 2 groups. Clinical success was 97.2% and 96.9% in chimney and BASILICA, respectively (P = 0.92). At 1-year follow-up, the cumulative incidence of major adverse cardiovascular events was 18.7% (95% CI: 11%-30.6%) in the chimney group and 19.9% (95% CI: 12.1%-31.5%) in the BASILICA group (log-rank P = 0.848), whereas chimney was associated with a numerically higher cardiovascular mortality than BASILICA (6.7% vs 1.3%; log-rank P = 0.168)., Conclusions: Chimney stenting and BASILICA effectively prevent TAVR-induced acute CO. Both techniques seem to have comparable acceptable periprocedural and 1-year outcomes., Competing Interests: Funding Support and Author Disclosures Dr Mangieri serves as a proctor for Kardia; has received speaker fees from Boston Scientific, Abbott Vascular, and Edwards Lifesciences; and has received institutional grants from Boston Scientific and Abbott Vascular. Dr Montorfano has received consultant fees from Abbott, Boston, Kardia, and Medtronic. Dr Latib is a consultant and serves on advisory boards for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Van Mieghem has received research grants from Abbott Vascular, Biotronik, Boston Scientific, Edwards Lifesciences, Medtronic, Daiichi-Sankyo, AstraZeneca, and Pie Medical; and has received advisory board/consultancy fees from Anteris, JenaValve, Amgen, Materialise, Siemens, Abbott Vascular, Biotronik, Boston Scientific, Medtronic, and Daiichi-Sankyo. Prof Abdel-Wahab declares that his hospital receives speaker honoraria and/or consultancy fees on his behalf from Boston Scientific, Medtronic, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There are no data comparing sirolimus-coated balloons (SCBs [MagicTouch, Concept Medical]) to paclitaxel-coated balloons (PCBs [SeQuent Please Neo, B. Braun]) for the treatment of de novo small vessel disease (SVD)., Objectives: This study sought to compare quantitative coronary angiographic outcomes at 6 months after treatment of de novo SVD with a PCB or SCB., Methods: This prospective, multicenter, noninferiority trial randomized 121 patients (129 SVD lesions) to treatment with an SCB or PCB, with balloon sizing determined using optical coherence tomography. The primary endpoint was noninferiority for the 6-month angiographic net lumen gain., Results: Angiographic follow-up was completed in 109 (90.1%) patients in the per-protocol analysis. The mean ± SD angiographic net gains were 0.25 ± 0.40 mm with SCBs vs 0.48 ± 0.37 mm with PCBs, resulting in SCBs failing to meet the 0.30 mm criterion for noninferiority (P noninferiority  = 0.173), with an absolute difference of -0.23 mm (95% CI: -0.37 to -0.09) secondary to a smaller late loss (0.00 ± 0.32 mm vs 0.32 ± 0.47 mm; P < 0.001) and more frequent late lumen enlargement (53.7% vs 30.0%; OR: 2.60; 95% CI: 1.22-5.67; P = 0.014) with PCBs. Binary restenosis rates were 32.8% and 12.5% following treatment with SCBs and PCBs, respectively (OR: 3.41; 95% CI: 1.36-9.44; P = 0.012). The mean angiography-derived fractional flow ratio at follow-up was 0.86 ± 0.15 following treatment with SCBs and 0.91 ± 0.09 following PCBs (P = 0.026); a fractional flow ratio ≤0.80 occurred in 13 and 5 vessels after treatment with SCBs and PCBs, respectively., Conclusions: The SCB MagicTouch failed to demonstrate noninferiority for angiographic net lumen gain at 6 months compared to the PCB SeQuent Please Neo., Competing Interests: Funding Support and Author Disclosures Dr Serruys has reported consultancy for Merillife, Novartis, SMT (Sahajanand Medical technological), Philips/Volcano, and Xeltis, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL)., Objectives: Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA., Methods: We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes., Results: Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort., Conclusion: In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined., Objectives: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD., Methods: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score)., Results: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (P interaction  = 0.049)., Conclusions: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA., Competing Interests: Funding Support and Author Disclosures Dr Palmerini has received speaker fees from Edwards Lifesciences and Medtronic. Dr Saia has received consulting and lecture fees from Abbott, Edwards Lifesciences, and Medtronic. Dr Kim has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Merill Life Sciences, and Shockwave Medical. Dr Søndergaard has received consulting fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and Sahajanand Medical Technologies. Dr Burzotta has received speaker fees from Abiomed, Abbott, Medtronic, and Terumo. Dr Romagnoli has received speaker fees by Abbott Vascular, Abiomed, and Medtronic. Dr Van Mieghem has received research grant support from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards Lifesciences, Abiomed, PulseCath BV, and Daiichi Sankyo. Dr Pilgrim has received research grants to his institution from Boston Scientific, Biotronik, and Edwards Lifesciences; and honoraria from Biotronik, Boston Scientific, Medtronic, Abbott, and HighLife SAS. Dr Adam has received personal and proctoring fees from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic (during the conduct of the study). Dr Di Mario has received research grants to his institution from Abbott, Amgen, Boston Scientific, Chiesi, Daiichi Sankyo, Edwards Lifesciences, and Volcano Philips. Dr Toggweiler has served as a proctor/consultant for Medtronic, Edwards Lifesciences, Biosensors, Boston Scientific, and Abbott Vascular; has served consultant for Medira, AtHeart Medical, Veosource, Shockwave, Teleflex, and Polares Medical; has received institutional research grants from Biosensors, Boston Scientific, and Fumedica; and holds equity in Hi-D Imaging. Dr Testa has received consulting fees from and served as a proctor Abbott, Boston Scientific, Medtronic, and Merrill. Dr Berti has served as a proctor for Edwards Lifesciences, Abbott, and Boston Scientific. Dr Ancona has received consultant fees from Abbott. Dr Montorfano has received proctor fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Castriota has received proctoring fees from Abbott and Medtronic. Dr Petronio has received consultant and research funds from Medtronic, Boston Scientific, and Abbott. Dr Barbanti has served as a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. Dr Tamburino has received speaker honoraria from Abbott and Medtronic. Dr Nickenig has received lecture or advisory board honoraria from Abbott, Amarin, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; owns stock options with Beren, Cardiovalve; has served in clinical trials with Abbott, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronik, Bristol Myers Squibb, Boehringer Ingelheim, CardioValve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi; and has received research funding from the Deutsche Forschungsgemeinschaft, the Bundeministerium für Bildung und Forschun, the European Union, Abbott, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Edwards Lifesciences, Medtronic, Novartis, and Pfizer. Dr Stefanini has received speaker fees from Abbott Vascular, Boston Scientific, and Pfizer/Bristol Myers Squibb; research grants to his institution from Boston Scientific. Dr Latib has served as a consultant for Abbott, Medtronic, Edwards Lifesciences, Boston Scientific, Neovasc, Shifamed, and Philips. Dr Porto has received consulting or speaker fees from Biotronik, Abiomed, Medtronic, Terumo, Philips, Sanofi, Amgen, Daiichi Sankyo, AstraZeneca, and Bayer, not related to this work. Dr Grube has served on the Speakers Bureau/Scientific Advisory Board for Medtronic, Boston Scientific, JenaValve, and High Life; and owns equity interest in Millipede, Pi-Cardia, Ancora, Laminar, ReNiva Medical, and Shockwave. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, and Infraredx; has served as a consultant for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, and Adona Medical; owns equity/options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; has a daughter who is an employee at Medtronic; and his employer (Mount Sinai Hospital) has received research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Philips, Biosense Webster, Shockwave, Vascular Dynamics, and V-wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome., Objectives: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV., Methods: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91])., Results: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm 2 vs 1.3 ± 0.8 cm 2 ; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176)., Conclusions: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR., Competing Interests: Funding Support and Author Disclosures Dr Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr Kim is a proctor for and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Abdel-Wahab has received speaker honoraria and/or consultancy fees to the hospital on his behalf from Boston Scientific and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and is an advisory board member for Biotronik. Dr Søndergaard has received consulting fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr Redwood is a proctor for and has received lecture fees from Edwards Lifesciences. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Sathananthan is a consultant to Edwards Lifesciences. Dr Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr Castriota is a proctor for Medtronic and Boston Scientific. Dr Nazif is a consultant for or has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and is a consultant for and holds equity in Venus Medtech. Dr Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr Latib has received institutional research and grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr Hildick-Smith is a proctor and adviser for Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Background: The first-generation ACURATE neo transcatheter heart valve (THV) (Boston Scientific) was associated with a non-negligible occurrence of moderate or greater paravalvular aortic regurgitation (AR) following transcatheter aortic valve replacement. To overcome this issue, the ACURATE neo2 iteration, which incorporates a taller outer skirt aimed at reducing the occurrence of paravalvular AR, has recently been developed., Objectives: The aim of this study was to assess the efficacy and safety of the ACURATE neo2 (Boston Scientific) THV in patients with severe aortic valve stenosis., Methods: ITAL-neo was an observational, retrospective, multicenter registry enrolling consecutive patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo THVs, via transfemoral and trans-subclavian access, in 13 Italian centers. One-to-one propensity score matching was applied to account for baseline characteristics unbalance. The primary endpoint was the occurrence of moderate or greater paravalvular AR on predischarge echocardiographic assessment. Secondary endpoints included postprocedural technical success and 90-day device success and safety., Results: Among 900 patients included in the registry, 220 received the ACURATE neo2 THV, whereas 680 were treated with the first-generation device. A total of 410 patients were compared after 1:1 propensity score matching. The ACURATE neo2 THV was associated with a 3-fold lower frequency of postprocedural moderate or greater paravalvular AR (11.2% vs 3.5%; P < 0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the 2 cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 at 90 days., Conclusions: Transfemoral transcatheter aortic valve replacement using the ACURATE neo2 was associated with a significant lower frequency of moderate or greater paravalvular AR compared with the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement (TAVI), although limited by degeneration of the bioprosthesis. "Redo" intervention itself is burdened by high risk of complications and valve-in-valve (ViV) TAVI could be a valid strategy of redo for patients with comorbidities., Methods and Results: Two independent reviewers screened all studies investigating patients undergoing ViV TAVI. Mortality at 30 days and at 1 year was the primary end point. Of 286 studies identified, 26 articles were included in this review with a total of 1448 patients. Median age was 78.8 years, 57.7% male. Median STS score and Logistic EuroSCORE were 9.4% and 31.3% respectively. Stenosis (45%) was the leading cause of prosthesis failure. Transfemoral approach was preferred (76%), with a prevalence of balloon expandable valves (73.3%). Mean follow up was 376 days. Overall and cardiovascular mortality at 30 days was 6.5% and 5.5% respectively, while at 1 year it was 14.5% and 8.9% respectively. At meta-regression analysis study year (p < .001), Logistic EuroSCORE (p < .01) and valve diameter ≤ 21 mm (p < .05) at 30 days, and stenosis as reason for failure (p = .05) at 1 year were identified as possible predictors of survival., Conclusions: ViV TAVI offers a valid strategy to treat high risk patients with a failure of bioprosthesis with satisfying results in terms of short and mid-term mortality. Future studies are needed to find predictors of long term survival and outcomes in lower risk patients., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS)., Background: Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published., Methods: The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year., Results: Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis., Conclusions: This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study reports an international experience using the transfemoral ACURATE neo transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) for the treatment of degenerated surgical aortic bioprostheses., Background: Transcatheter valve-in-valve procedures have emerged as an alternative to redo surgery. Supra-annular prostheses might be particularly useful in this indication., Methods: This is an international multicenter analysis including 85 patients from 14 centers in Europe and Canada undergoing an ACURATE neo valve-in-valve procedure from March 2015 to February 2019., Results: Internal diameter of the degenerated bioprosthesis was 20.3 ± 2.1 mm. Prosthesis size S was used in 70 (82%) procedures. The median depth of implantation was 3 mm and the upper crown of the ACURATE neo was positioned above the stent posts of the degenerated bioprosthesis in 54 (64%) and inside in 31 (36%). Mean transvalvular gradient before discharge was significantly lower if the upper crown was above the degenerated bioprosthesis (13.7 ± 5.9 mm Hg vs. 19.5 ± 10.0 mm Hg; p = 0.001). However, a high position of the ACURATE neo resulted in embolization in 1 patient, conversion to open-heart surgery in 1, and need for reintervention due to transcatheter heart valve failure within the first 18 months of follow-up in 4., Conclusions: This early experience shows that a high implantation of the ACURATE neo with the upper crown above the stent posts of the degenerated bioprosthesis resulted in lower mean transvalvular gradients but a higher rate of malpositioning and early valve degeneration., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to evaluate the clinical efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS)., Background: The need to minimize the risk for plaque debris prolapsing between stent struts following CAS has resulted in the development of DLS. Small clinical studies evaluating 2 available devices, Roadsaver and CGuard, have been recently published; none of these studies is sufficiently powered to test the role of common risk factors on the occurrence of stroke at 30 days post-CAS., Methods: A search was performed of multiple electronic databases for studies larger than 100 cases of CAS with DLS. Four single-arm prospective studies were identified, and individual patient data were collected. The primary endpoint was the occurrence of stroke at 30 days; secondary endpoints were technical and procedural success, periprocedural stroke, and in-hospital and 30-day rates of death., Results: The Roadsaver and CGuard stents were used in similar proportions, and technical success was achieved in all procedures (100% [n = 556]). There were 6 periprocedural strokes (1.08%; all minor). During 30-day follow-up, there was 1 death (0.17%) from myocardial infarction and 1 additional minor stroke (0.17%). The cumulative 30-day mortality rate was 0.17%, and the incidence of stroke at 30 days was 1.25%. No predictors of stroke at 30 days could be identified., Conclusions: This meta-analysis suggests that DLS can be safely used for CAS, and their use minimizes the incremental risk related to symptomatic status and other risk factors., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but frequency-domain optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique, which allows physiopathologic assessment of coronary plaque. We investigated the possible relation between OCT and FFR in selected ICL patients., Methods: Stable or unstable patients with ICL who underwent both FFR and OCT assessment at two large tertiary centers were retrospectively enrolled. FFR was performed according to standard methodology. OCT images were (on blind to clinical and FFR results) analyzed to assess minimal lumen area (MLA), percentage area stenosis (AS), thrombus and plaque ulceration., Results: Forty patients were identified (62±10years, 93% symptomatic, 35% acute presentation, 93% left-anterior-descending artery ICL). Percentage diameter stenosis at quantitative coronary angiography was 40±12% and FFR was 0.85±0.07. MLA (p=0.009), AS (p<0.001) and plaque ulceration (p=0.02) were significantly associated with FFR values. An integrated assessment of AS (≥ or <70%), MLA (≥ or <2.5mm 2 ) and presence or absence of thrombus and plaque ulceration was found to have the potential to accurately (sensitivity 91%, specificity 93%) predict FFR results., Conclusion: In patients with ICL, a combination of different OCT parameters may help predict FFR results. These findings suggest that only a comprehensive assessment of lesion features by OCT can allow an accurate prediction of lesion severity assessed by FFR., (Copyright © 2017. Published by Elsevier B.V.)

Double Right Coronary Artery (RCA) is one of the rarest congenital coronary anomalies. Although it can be regarded as a benign condition in the vast majority of cases, it has been associated with acute and life-threatening presentations, including inferior ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and complete heart block, tachyarrhythmias, or even sudden death. However, the role of a double RCA in these conditions is yet to be clarified as more recent data prove no statistically significant association between prevalence of significant atherosclerosis in anomalous coronary arteries in comparison to normal coronary arteries. Here we present a case of inferior STEMI in the context of double RCA, in which one of the two component branches was accidentally found after an "unexpected" jump of the coronary guidewire to treat what was initially considered the main vessel., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Patients with failed bioprostheses are an increasing population at high risk for redo surgery. Valve-in-valve transcatheter aortic valve implantation is a promising alternative but a limited number of first-generation devices have proven efficacy in all cases., Methods: Patients with degenerated bioprostheses at high risk for redo surgery were included in the registry after being assigned to valve-in-valve intervention by a local heart team. Main basal and follow-up data (at 1 month and 6 months) of patients undergoing valve-in-valve transcatheter aortic valve implantation with the Lotus valve system (Boston Scientific, Natick, MA) in three high-volume Italian centers were entered in the registry., Results: Twelve patients (aged 71.1 ± 14.1 years, 66% male, logistic European System for Cardiac Operative Risk Evaluation score 28.8 ± 22.9) were included in the registry. Implantation success rate was 92%; in 1 patient, the valve was completely retrieved because of unsatisfactory gradients after valve positioning. All procedures were done through femoral access, and all but one required only local anesthesia. In patients with stenosis as pure or mixed mechanism for degeneration (n = 7), mean ventriculoaortic gradient decreased from 46.7 ± 7.0 mm Hg to 16.6 ± 5.7 mm Hg (p < 0.001). No patients had more than mild aortic regurgitation at hospital discharge. Results where confirmed at 1-month and 6-month follow-up, with improvement of New York Heart Association functional status in all patients (functional class I to II in 100% of patients)., Conclusions: The valve-in-valve procedure using the Lotus valve is a feasible alternative to repeat surgery in high-risk patients with degenerated bioprostheses. Using the Lotus valve in this challenging and increasingly frequent scenario could offer a safe and effective strategy that should be explored in larger clinical trials., (Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs)., Background: Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment., Methods: Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure., Results: A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non-procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months)., Conclusions: PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We assessed whether exercise stress test (EST) results are related to the presence of coronary microvascular dysfunction (CMVD) in patients undergoing elective percutaneous coronary intervention (PCI)., Background: Previous studies showed that EST is poorly reliable in predicting restenosis after PCI; some studies also showed CMVD in the territory of the treated vessel., Methods: We studied 29 patients (age 64 ± 6, 23 M) with stable coronary artery disease and isolated stenosis (>75%) of the left anterior descending (LAD) coronary artery, undergoing successful PCI with stent implantation. EST and assessment of coronary microvascular function were performed 24h, 3 months and 6 months after PCI. Coronary blood flow (CBF) response to adenosine and to cold-pressor test (CPT) was assessed in the LAD coronary artery by transthoracic Doppler echocardiography., Results: Patients with ST-segment depression ≥ 1 mm at EST performed 24h after PCI (n=11, 38%) showed a lower CBF response to adenosine compared to those with negative EST (1.65 ± 0.4 vs. 2.11 ± 0.4, respectively, p=0.003), whereas the difference in CBF response to CPT was not significant (1.44 ± 0.4 vs. 1.64 ± 0.3, respectively; p=0.11). At 3-month and 6-month follow-up a positive EST was found in 12 (41%) and 13 (44%) patients, respectively; patients with positive EST also had lower CBF response to adenosine compared to those with negative EST (3 months: 1.69 ± 0.3 vs. 2.20 ± 0.3, respectively; 6 months: 1.66 ± 0.2 vs. 2.32 ± 0.3, respectively; p<0.001 for both)., Conclusions: Positive EST after elective successful PCI consistently reflects impairment of hyperemic CBF due to CMVD, which persists over a follow-up period of 6 months., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Objective: To assess the effect of ranolazine on systemic vascular function in patients with type II diabetes mellitus (T2DM)., Methods: We randomized 30 consecutive T2DM patients with no evidence of cardiovascular disease and no insulin therapy to receive one of the following 3 forms of treatment in a blinded fashion: ranolazine, 375 mg bid for 3 weeks (group 1); ranolazine, 375 mg bid for 2 weeks, followed by placebo bid for 1 week (group 2); placebo bid for 3 weeks (group 3). Flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) of the right brachial artery were assessed at baseline and after 48 h, and 2 and 3 weeks., Results: FMD and NMD were similar among groups at baseline. Compared to the basal value, FMD significantly improved after 2 weeks in group 1 and in group 2 (p < 0.01 for both), but not in group 3. At 3 weeks, FMD remained improved, compared to baseline, in group 1 (p < 0.05), whereas returned to basal values in group 2 (p = 0.89 vs. baseline). No changes in NMD were observed in any group., Conclusions: In this controlled study, ranolazine was able to improve endothelial function in T2DM patients., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background and Aims: To assess the effects of bariatric surgery (BS) on peripheral endothelial function and on coronary microvascular dilator function., Methods and Results: We studied 50 morbidly obese patients (age 38 ± 9, 13 M) who underwent BS and 20 comparable obese controls (age 41 ± 11, 6 M) without any evidence of cardiovascular disease. Peripheral vascular dilator function was assessed by brachial artery diameter changes in response to post-ischemic forearm hyperaemia (flow-mediated dilation, FMD). Coronary microvascular function was assessed by measuring coronary blood flow (CBF) velocity response to i.v. adenosine and to cold pressor test (CPT) in the left anterior descending coronary artery by transthoracic Doppler echocardiography. The tests were performed at baseline and at 3-month follow-up. At baseline, FMD and CBF response to adenosine and CPT were similar in the 2 groups. Compared to baseline, FMD at follow-up improved significantly in BS patients (5.9 ± 2.7% to 8.8 ± 2.4%, p < 0.01), but not in controls (6.3 ± 3.2% vs. 6.4 ± 3.1%, p = 0.41). Similarly, a significant improvement of CBF response to adenosine (1.63 ± 0.47 to 2.45 ± 0.57, p < 0.01) and to CPT (1.43 ± 0.26 to 2.13 ± 0.55, p < 0.01) was observed in BS patients but not in controls (1.55 ± 0.38 vs. 1.53 ± 0.37, p = 0.85; and 1.37 ± 0.26 vs. 1.34 ± 0.21, p = 0.48, respectively). The favourable vascular effects of BS were similar independently of the presence and changes of other known cardiovascular risk factors and of basal values and changes of serum C-reactive protein levels., Conclusions: Our data show that, in morbidly obese patients, together with peripheral endothelial function, BS also improves coronary microvascular function. These effects suggest global improvement of vascular function which can contribute significantly to the reduction of cardiovascular risk by BS reported in previous studies., (Copyright © 2010 Elsevier B.V. All rights reserved.)