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Background: New conduction disturbances are frequent after transcatheter aortic valve implantation (TAVI). Refining our ability to predict high-grade atrioventricular block (AVB) occurring later than 24 hours after the procedure would be useful in order to select patients eligible for early discharge., Aims: This study was designed to identify predictors of high-grade AVB occurring between 24 hours and 30 days after TAVI and to develop and validate a predictive risk score., Methods: We analysed clinical, procedural, and electrocardiographic parameters of 1,290 TAVI patients. Independent predictors of delayed high-grade AVB were used to develop the predictive score, which was then externally validated in a cohort of 936 patients., Results: Implantation of self-expanding valves, greater implantation depth, longer PR interval in preprocedural electrocardiogram (ECG) and greater increase of PR duration in next-day ECG, preprocedural right bundle branch block (RBBB) and new-onset left bundle branch block or RBBB that persisted in next-day ECG were independent predictors of delayed high-grade AVB and were combined to develop the Delayed atrioventricular block Prediction for eArly disChargE (D-PACE) score. The areas under the curve of the score were 0.879 (95% confidence interval [CI]: 0.835-0.923) and 0.799 (95% CI: 0.730-0.868) in the derivation and validation cohorts, respectively. Based on the score, patients can be classified into three risk categories; low-risk patients demonstrated an incidence of delayed AVB of less than 1% and are ideal candidates for next-day discharge., Conclusions: The D-PACE score can be used to stratify TAVI patients according to their risk of delayed high-grade AVB and thereby identify those suitable for next-day discharge.

Objectives: Thoracic/abdominal aortic aneurysms and aortic stenosis may be concomitant diseases requiring both transcatheter aortic valve implantation (TAVI) and endovascular aneurysm repair (T/EVAR) in high-risk patients for surgical approaches, but temporal management is not clearly defined yet. The aim of the study was to analyse outcomes of simultaneous versus staged TAVI and T/EVAR., Methods: Retrospective observational multicentre study was performed on patients requiring TAVI and T/EVAR from 2016 to 2022. Patients were divided into 2 groups: 'Simultaneous group' if T/EVAR + TAVI were performed in the same procedure and 'Staged group' if T/EVAR and TAVI were performed in 2 steps, but within 3 months. Primary outcomes were technical success, 30-day mortality/major adverse events and follow-up survival. Secondary outcomes were procedural metrics and length of stay., Results: Forty-four cases were collected; 8 (18%) had T/EVAR and 36 (82%) had EVAR, respectively. Upon temporal determination, 25 (57%) and 19 (43%) were clustered in Simultaneous and Staged groups, respectively. In Staged group, median time between procedures was 72 (interquartile range-IQR: 57-87) days. Preoperative and intraoperative figures were similar. There was no difference in 30-day mortality (Simultaneous: 0/25 versus Staged: 1/19; P = 0.43). Pulmonary events (Simultaneous: 0/25 versus Staged: 5/19; P = 0.01) and need of postoperative cardiac pacemaker (Simultaneous: 2/25 versus Staged: 7/19; P = 0.02) were more frequent in Staged patients. The overall length of stay was lower in the Simultaneous group [Simultaneous: 7 (IQR: 6-8) versus Staged: 19 (IQR: 15-23) days; P = 0.001]. The median follow-up was 25 (IQR: 8-42) months and estimated 3-year survival was 73% with no difference between groups (Simultaneous: 82% versus Staged: 74%; P = 0.90)., Conclusions: Both Simultaneous or Staged T/EVAR and TAVI procedures are effective with satisfactory outcomes. Despite the small numbers, simultaneous repair seems to reduce length of stay and pulmonary complications, maintaining similar follow-up survival., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Mycolicibacterium hassiacum (homotypic synonym: Mycobacterium hassiacum ) represents an ungrouped thermotolerant rapidly growing mycobacteria (RGM) species occasionally associated with infections and disease in humans. In this report, we describe a case of pyogranulomatous dermatitis and panniculitis due to M. hassiacum in an immunocompetent adult cat. To the best of our knowledge, this represents the first report of M. hassiacum infection in animals. We also report the results of the in-depth genome characterization of the isolate using a combined short- and long-read whole-genome sequencing (WGS) approach. We observed the lack of acquired-resistance genes and no evidence of mutations in housekeeping genes associated with resistance to rifampicin and isoniazid. We detected some virulence factors in our isolate, such as some associated with the interaction of mycobacteria with host cells, and the presence of multiple copies of heavy metal resistance genes ( ars B, ars R, and ars L/ cad L). In conclusion, M. hassiacum should be included among the RGM species associated with feline subcutaneous atypical mycobacteriosis (SAM). A reliable and fast RGM laboratory identification and characterization is important not only for an accurate etiological diagnosis but also for a correct approach to SAM treatment options.

Data deriving from patients who underwent TAVR between 2007 and 2017 in 13 Italian centers were prospectively collected. Patients were stratified in those with normal LVEF and reduced LVEF. The latter was further classified according to ischemic or nonischemic etiology. The primary end point was a composite of all-cause death and rehospitalizations; the secondary end points were the isolated composers of the primary end point and cardiac death. Overall, 2,626 patients were included in the analysis: 68.1% with normal LVEF and 31.9% with reduced LVEF. At 8 years, reduced LVEF was significantly associated with the primary end point (adjusted hazard ratio 1.17, 95% confidence interval 1.06 to 1.29). Consistent findings were evident for the composite end point. No differences in these trends were found at the 30-day landmark analyses. Compared with nonischemic etiology, ischemic reduced LVEF was associated with an increased risk of cardiac death (adjusted hazard ratio 1.43, 95% confidence interval 1.02 to 2.02). In conclusion, patients with reduced LVEF who underwent TAVR are exposed to a progressively increased risk of death and rehospitalizations, even at very long-term follow-up., Competing Interests: Declaration of competing interest CG, MA, and MDC received speaker fees from Medtronic; FB received consultant/proctor fees from Medtronic; MM received consultant fees from Abbott, Boston, Kardia and Medtronic; TP received lectures fees from Medtronic, Edwards and Abbott. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) in native pure aortic regurgitation (AR) with off-label use of balloon-expandable valves (BEV) has been reported. However, there are scant data regarding optimal oversizing and its safety, and our study assessed BEV oversizing and outcomes of TAVI. Thirteen consecutive tricuspid aortic valve patients who underwent transfemoral TAVIs for pure AR with Sapien BEV at our center between 2019 and 2023 (69.2% males, mean age 80.8 years, Society of Thoracic Surgeons 4.0%) were divided into small annulus (SA) group (≤618 mm 2 ) where ≥20% oversizing is achievable based on published data on BEV overexpansion, and larger annulus (LA) group (>618 mm 2 ). Overexpansion and actual oversizing were measured on postprocedural computed tomography scan. Technical success was 92.3% with 1 valve embolization in the LA group. The postprocedural computed tomography showed a mean 28.3% oversizing, significantly higher in SA (31.2%) than in LA group (19.4%), p = 0.0092. Oversizing ≥20% was achieved in 100% SA versus 33.3% LA patients (p = 0.046). In conclusion, TAVI in pure AR with oversized Sapien BEV showed good procedural and short-term outcomes when ≥20% oversizing was predictably achievable., Competing Interests: Declaration of competing interest Francesco Saia reports a relationship with Edwards Lifesciences, Abbott Vascular and Medtronic that includes consulting or advisory and speaking and lecture fees. Tullio Palmerini reports a relationship with Edwards Lifesciences and Medtronic that includes speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) has become the standard treatment for severe aortic valve stenosis in patients at increased surgical risk. Percutaneous transfemoral (TF) is the access of choice due to its reduced invasiveness and perioperative morbidity/mortality compared with the trans-axillary, aortic, and apical routes. On the other hand, vascular access complications (VACs) of the TF access are associated with prolonged hospitalization, 30-day, and 1-year mortality. In addition, the concomitance of peripheral arterial disease may require associated endovascular management. A multidisciplinary team with Interventional Cardiologists and Vascular Surgeons may minimize the rate of VACs in patients with challenging femoral-iliac access or concomitant disease of other vascular districts, thus optimizing the outcome of TF-TAVI. The aim of this study was to evaluate the role of Vascular Surgeons in TF TAVI procedures., Methods: We conducted a retrospective single-center review of all TF-TAVI procedures assisted by Vascular Surgeons between January 2016 and December 2020 in a high-volume tertiary hospital. Pre, intra, and postoperative data were analyzed by a dedicated group of Interventional Cardiologists and Vascular Surgeons. VACs were defined according with the Valve Academic Research Consortium (VARC) three guidelines. The outcomes of TF-TAVI procedures with Vascular Surgeons involvement were assessed as study's endpoints., Results: Overall, 937 TAVI procedures were performed with a TF approach ranging between 78% (2016) and 98% (2020). Vascular Surgeons were involved in 67 (7%) procedures with the following indications: concomitant abdominal aortic aneurysm (EVAR + TAVI) - 3 (4%), carotid stenosis (TAVI + CAS) - 2 (3%), hostile femoral/iliac access, or VACs - 62 (93%). Balloon angioplasty of iliac artery pre-TAVI implantation was performed in 51 cases (conventional PTA: 38/51%-75%; conventional PTA + intravascular lithotripsy: 13/51%-25%; stenting: 5/51%-10%). TAVI procedure was successfully completed by percutaneous TF approach in all 62 cases with challenging femoral/iliac access. VACs necessitating interventions were 18/937 (2%) cases, localized to the common femoral or common/external iliac artery in 15/18 (83%) and 3/18 (17%) cases, respectively. They were managed by surgical or endovascular maneuvers in 3/18 (17%) and 15/18 (83%) cases, respectively. Fifteen/18 (83%) VACs were treated during the index procedure. There was no procedure-related mortality or 30-day readmission., Conclusion: In our experience, Vascular Surgeon assistance in TAVI procedures was not infrequent and allowed safe and effective device introduction through challenging TF access. Similarly, the concomitant significant disease of other vascular districts could be safely addressed, potentially reducing postoperative related mortality and morbidity. The implementation of multidisciplinary team with interventional cardiologists and vascular surgeons should be encouraged whenever possible., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown., Aims: We sought to compare different PCI timing strategies in TAVI patients., Methods: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method., Results: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days., Conclusions: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Background: Drug-coated balloons (DCBs) have shown comparable results with drug-eluting stents in small vessel disease (SVD) percutaneous coronary intervention (PCI) in terms of target vessel revascularization and a reduced incidence of myocardial infarction. However, the relatively high rate of bail-out stenting (BOS) still represents a major drawback of DCB PCI., Aims: The aim of the study was to investigate the clinical, anatomic, and procedural features predictive of BOS after DCB PCI in SVD., Methods: We included all consecutive patients undergoing PCI at our institution between January 2020 and May 2022 who were treated with DCB PCI of a de novo lesion in a coronary vessel with a reference vessel diameter (RVD) between 2.0 and 2.5 mm. Angiographic success was defined as a residual stenosis <30% without flow-limiting dissection. Patients who did not meet these criteria underwent BOS., Results: A total of 168 consecutive patients and 216 coronary stenoses were included. The rate of bail-out stent was 13.9%. On multivariate analysis, DCB/RVD ratio (odds ratio [OR]: 4.39, 95% confidence interval [CI]: 1.71-11.29, p < 0.01), vessel tortuosity (OR: 7.00, 95% CI: 1.66-29.62, p < 0.01), distal vessel disease (OR: 5.66, 95% CI: 2.02-15.83, p < 0.01), and high complexity (Grade C of ACC/AHA classification) coronary stenoses (OR: 6.31, 95% CI: 1.53-26.04, p = 0.01) were independent predictors of BOS., Conclusions: BOS is not an infrequent occurrence in DCB PCI of small vessels and is correlated with vessel tortuosity, distal diffuse vessel disease, higher lesion complexity, and balloon diameter oversizing., (© 2023 Wiley Periodicals LLC.)

Background: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce., Aims: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3)., Methods: The SAPIEN 3 Ultra registry included consecutive patients who underwent transfemoral TAVI at 12 European centres with the S3U or S3 between October 2016 and December 2020. One-to-one propensity score (PS) matching was performed to account for differences in baseline characteristics. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke and hospitalisation for heart failure at 1 year., Results: The overall study cohort encompassed 1,692 patients treated with either the S3U (n=519) or S3 (n=1,173). The PS-matched population had a total of 992 patients (496 per group). At 1 year, the rate of death from any cause was 4.9% in the S3U group and 6.3% in the S3 group (p=0.743). Similarly, there were no significant differences in the rates of the primary composite outcome (9.5% in the S3 group and 6.6% in the S3U group; p=0.162). The S3U was associated with lower rates of mild paravalvular leak (PVL) compared with the S3 (odds ratio 0.63, 95% confidence interval: 0.44 to 0.88; p<0.01). No significant differences in transprosthetic gradients were observed between the two groups., Conclusions: Compared with the S3, the S3U transcatheter heart valve was associated with similar 1-year clinical outcomes but reduced rates of mild PVL.

Aims: Several causes have been reported for coronary artery ectasia (CAE), mostly atherosclerosis and tunica media abnormalities. The main aim of the present study was to investigate if CAE extension differs in distinct clinical settings., Methods: Three hundred and forty-one patients with diagnosis of CAE were identified among 9659 coronary angiographies and divided into four groups according to the patient's admission diagnosis: stable or unstable angina (S-UA), myocardial infarction (MI), aortic disease, aortic valvular disease (AVD). S-UA and MI were subgrouped according to the presence of obstructive coronary artery disease (OCAD). Multivariable logistic regression was used to investigate the relationship between clinical diagnosis and CAE extension as expressed by Markis classification and number of coronary vessels affected by CAE., Results: No significant differences in CAE extension were found among the four groups, in terms of vessels affected by CAE (P = 0.37) or Markis class (P = 0.33). CAE was not related to the extension of OCAD as assessed by the Gensini score, which was higher in MI and S-UA groups (P < 0.01). However, when ischemic patients were sub-divided on the basis of the presence of OCAD, MI without obstructive coronary artery disease (MINOCA) was associated with a higher extension of CAE in terms of Markis class 1 (OR 5.08, 95% CI 1.61-16.04; P < 0.01)., Conclusion: The extension of CAE is comparable in patients referred to coronary angiography for different clinical scenarios, including S-UA, MI, aortic disease, and AVD; however, patients with MINOCA were associated with a higher extension of CAE.Graphical abstract: Difference in coronary artery ectasia extension in terms of Markis class severity, respectively, stratified by clinical presentation and obstructive coronary artery disease presence, http://links.lww.com/JCM/A519., (Copyright © 2023 Italian Federation of Cardiology - I.F.C. 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.)

Transcatheter aortic valve implantation (TAVI) in noncalcified pure aortic valve regurgitation is challenging as dedicated valves are not widely available. We present a case series of four inoperable patients who underwent compassionate TAVI for this indication at our institution with a balloon-expandable valve. In this context, we analyzed the relevant technical aspects such as the need for larger oversizing of the transcatheter prosthesis and the safety and limits of valve overexpansion., (© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence., Methods: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years., Results: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio' 0.88 [95% CI, 0.66-1.18]; P =0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio' 0.97 [95% CI, 0.76-1.24]; P =0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10)., Conclusions: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

The risk of bleeding as predicted by the PRECISE-DAPT score can vary over time after percutaneous coronary intervention (PCI). We sought to compare the predictive ability of the PRECISE-DAPT score calculated at baseline and reassessed during follow-up in male and female patients undergoing PCI. The RE-SCORE was a multicenter, prospective registry including patients undergoing PCI treated with dual antiplatelet therapy (DAPT) for 1 year. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding. The PRECISE-DAPT score was determined for each patient at the time of PCI and at 1, 4 and 8-month follow-up visits or before the occurrence of an endpoint event. A total of 480 patients undergoing PCI were included. At baseline, median PRECISE-DAPT score was similar in males (23.2 [IQR 20.1-24.2]) and females (23.4 [IQR 20.2-25.3]; p = .22). During follow-up, an increase in the PRECISE-DAPT occurred significantly more often in females (44%) than in males (23%; p < .001). The discrimination of the PRECISE-DAPT score calculated at baseline was marginal in both males (c-index = 0.59, 95% CI: 0.51-0.65) and females (c-index = 0.55, 95% CI: 0.49-0.60). The discriminative ability of the score reassessed at follow-up was excellent in females (c-index = 0.84; 95% CI: 0.77-0.91) but remained modest in males (c-index = 0.61; 95% CI: 0.55-0.70). The bleeding predictive ability of the PRECISE-DAPT score can vary over time, more commonly in females than males. The discrimination of the score calculated during follow-up appeared improved in females but remained modest in males. Clinical Trial Registration - ClinicalTrials.gov Identifier: NCT03526614.

Background: Antiplatelet therapy deescalation has been suggested as an alternative to standard treatment with potent dual antiplatelet therapy (DAPT) for 1 year in low bleeding risk patients with acute coronary syndromes undergoing percutaneous coronary intervention to mitigate the increased risk of bleeding. Whether this strategy preserves the ischemic and survival benefits of potent DAPT is uncertain., Methods: We performed a pairwise meta-analysis in patients with acute coronary syndrome undergoing percutaneous coronary intervention treated with either 1-year standard potent DAPT versus deescalation therapy (potent DAPT for 1-3 months followed by either reduced potency DAPT or ticagrelor monotherapy for up to 1 year). Randomized trials comparing standard DAPT versus deescalation therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary end point was 1-year all-cause mortality., Results: The meta-analysis included 6 trials in which 20 837 patients were randomized to potent DAPT for 1 to 3 months followed by deescalation therapy for up to 1 year (n=10 392) or standard potent DAPT for 1 year (n=10 445). Deescalation therapy was associated with lower 1-year rates of all-cause mortality compared with standard therapy (odds ratio, 0.75 [95% CI, 0.59-0.95]; P =0.02). Deescalation therapy was also associated with lower rates of major bleeding (odds ratio, 0.59 [95% CI, 0.48-0.72]; P <0.0001), with no significant difference in major adverse cardiac events (major adverse cardiovascular events; odds ratio, 0.89 [95% CI, 0.77-1.04]; P =0.14)., Conclusions: In low bleeding risk patients with acute coronary syndrome undergoing percutaneous coronary intervention, compared with 1-year of potent DAPT, antiplatelet therapy deescalation therapy after 1 to 3 months was associated with decreased mortality and major bleeding with similar rates of major adverse cardiovascular events.

Competing Interests: Funding Support and Author Disclosures Dr Palmerini has received personal fees from Abbott and Edwards Lifesciences outside the submitted work. Dr. Saia has received consulting fees from Abbott Vascular, Eli Lilly, AstraZeneca, and St. Jude Medical; and speaker fees from Abbott Vascular, Eli Lilly, AstraZeneca, St. Jude Medical, Terumo, Biosensors, Edwards Lifesciences, and Boston Scientific outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Study Design: To compare arterial inflammation (AI) between people living with HIV (PLWH) and uninfected people as assessed by 18 F-Fluorodeoxyglucose ( 18 F-FDG)-positron emission tomography (PET)., Methods: We prospectively enrolled 20 PLWH and 20 uninfected people with no known cardiovascular disease and at least 3 traditional cardiovascular risk factors. All patients underwent 18 F-FDG-PET/computed tomography (CT) of the thorax and neck. Biomarkers linked to inflammation and atherosclerosis were also determined. The primary outcome was AI in ascending aorta (AA) measured as mean maximum target-to-background ratio (TBR max ). The independent relationships between HIV status and both TBR max and biomarkers were evaluated by multivariable linear regression adjusted for body mass index, creatinine, statin therapy, and atherosclerotic cardiovascular 10-year estimated risk (ASCVD)., Results: Unadjusted mean TBR max in AA was slightly higher but not statistically different (P = .18) in PLWH (2.07; IQR 1.97, 2.32]) than uninfected people (2.01; IQR 1.85, 2.16]). On multivariable analysis, PLWH had an independent risk of increased mean log-TBR max in AA (coef = 0.12; 95%CI 0.01,0.22; P = .032). HIV infection was independently associated with higher values of interleukin-10 (coef = 0.83; 95%CI 0.34, 1.32; P = .001), interferon-γ (coef. = 0.90; 95%CI 0.32, 1.47; P = .003), and vascular cell adhesion molecule-1 (VCAM-1) (coef. = 0.75; 95%CI: 0.42, 1.08, P < .001)., Conclusions: In patients with high cardiovascular risk, HIV status was an independent predictor of increased TBR max in AA. PLWH also had an increased independent risk of IFN-γ, IL-10, and VCAM-1 levels., (© 2021. The Author(s).)

Background: Coronary obstruction following transcatheter aortic valve replacement (TAVR) is a life-threatening complication. For patients at elevated risk, it is not known how valve choice is influenced by clinical and anatomic factors and how outcomes differ between valve platforms. For patients at high risk of coronary obstruction, we sought to describe the anatomical and clinical characteristics of patients treated with both balloon-expandable (BE) and self-expanding (SE) valves., Methods: This was a multicenter international registry of patients undergoing TAVR who are considered to be at high risk of coronary obstruction and receiving pre-emptive coronary protection., Results: A total of 236 patients were included. Patients receiving SE valves were more likely to undergo valve-in-valve procedures and also had smaller sinuses of Valsalva and valve-to-coronary distance. Three-year cardiac mortality was 21.6% with SE vs 3.7% with BE valves. This was primarily driven by increased rates of definite or probable coronary occlusion, which occurred in 12.1% of patients with SE valves vs 2.1% in patients with BE valves., Conclusions: In patients undergoing TAVR with coronary protection, those treated with SE valves had increased rates of clinical and anatomic features that increase the risk of coronary obstruction. These include an increased frequency of valve-in-valve procedures, smaller sinuses of Valsalva, and smaller valve-to-coronary distances. These patients were observed to have increased cardiac mortality compared with patients treated with BE valves, but this is likely due to their higher risk clinical and anatomic phenotypes rather than as a function of the valve type itself., Competing Interests: Dr Palmerini has received personal fees from Abbott and Edwards Lifesciences. Dr Oakley is a consultant for Edwards Lifesciences. Dr Burzotta received speaker’s fees from Abiomed, Abbott, and Medtronic. Mr Makkar has received research grants from 10.13039/100006520Edwards Lifesciences, 10.13039/100001316Abbott, 10.13039/100004374Medtronic, and 10.13039/100008497Boston Scientific; has served as the national principal investigator for Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific. All other authors declare no conflict of interest., (© 2022 The Authors.)

Background: The presence of severe calcific atherosclerosis at the iliofemoral axis may preclude transcatheter aortic valve implantation (TAVI) by the transfemoral (TF) approach. Intravascular lithotripsy (IVL) is a novel technology that fractures intimal/medial calcium and increases vessel compliance allowing TF TAVI in selected patients with peripheral artery disease (PAD)., Aims: The aim of this study was to report on the safety and efficacy of IVL-assisted TF TAVI in an all-comers population., Methods: Clinical, imaging and procedural data on all consecutive patients treated by IVL-assisted TF TAVI in six high-volume European centres (2018-2020) were collected in this prospective, real-world, multicentre registry., Results: IVL-assisted TF TAVI was performed in 108 patients, increasing from 2.4% to 6.5% of all TAVI from 2018 to 2020, respectively. The target lesion was most often localised at the common and/or external iliac artery (93.5% of cases; average TL-MLD 4.6±0.9 mm with 318 degrees of calcium arc). Transfemoral aortic valve delivery was successful in 100% of cases; final procedural success in 98.2% (two conversions to cardiac open surgery for annular rupture and valve migration). Complications of the IVL-treated segments consisted of 1 perforation and 3 major dissections requiring stent implantation (2 covered stents and 2 BMS). Access-site-related complications included 3 major bleedings. Three in-hospital deaths were recorded (2.8%, 1 failed surgical conversion after annular rupture, 1 cardiac arrest after initial valvuloplasty, 1 late hyperkalaemia in renal dysfunction)., Conclusions: IVL-assisted TF TAVI proved to be a safe and effective approach, which helps to expand the indications for TF TAVI in patients with severe calcific PAD. However, these patients continue to have a higher-than-average incidence of periprocedural complications.

Aims: To investigate gender difference in mortality among patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous angioplasty (PPCI)., Methods: We analyzed data from the prospective registries of two hub PPCI centres over a 10-year period to assess the role of female gender as an independent predictor of both all-cause and cardiac death at 30 days and 1 year. To account for all confounding variables, a propensity score (PS)-adjusted multivariable Cox regression model and a PS-matched comparison between the male and female were used., Results: Among 4370 consecutive STEMI patients treated with PPCI at participating centres, 1188 (27.2%) were women. The survival rate at 30 days and 1 year were significantly lower in women (Log-rank P-value < 0.001). At PS-adjusted multivariable Cox regression analysis, female gender was independently associated with an increased risk of 30-day all-cause death [hazard ratio (HR) = 2.09; 95% confidence interval (CI): 1.45-3.01, P < 0.001], 30-day cardiac death (HR = 2.03;95% CI:1.41-2.93, P < 0.001), 1-year all-cause death (HR = 1.45; 95% CI:1.16-1.82, P < 0.001) and 1-year cardiac death (HR = 1.51; 95% CI:1.15-1.97, P < 0.001). For the study outcome, we found a significant interaction of gender with the multivessel disease in females who were at increased risk of mortality in comparison with men in absence of multivessel disease. After the PS matching procedure, a subset of 2074 patients were identified. Women still had a lower survival rate and survival free from cardiac death rate both at 30-day and at 1-year follow-up., Conclusion: As compared with men, women with STEMI treated with PPCI have higher risk of both all-cause death and cardiac mortality at 30-day and 1-year follow-up., (Copyright © 2022 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Competing Interests: Competing interests: None declared.

Background: Coronary artery ectasia (CAE) is associated with ascending aortic (AA) ectasia. The purpose of this study is to evaluate the diagnostic performance of different echocardiographic parameters (EP) in predicting the presence of CAE., Methods: Four hundred-eighteen patients with AA ectasia candidate to coronary angiography were identified and divided in two groups in respect of the presence of CAE. Receiver-operating characteristic curves areas (AUC) were used to assess the discrimination power of the following EP: aortic annulus diameter, sinuses of Valsalva (SV) diameter, sino-tubular junction (STJ) diameter, AA diameter, STJ to SV ratio (STJ-to-SV) and STJ to AA ratio (STJ-to-AA). All these parameters were indexed by body surface area. The relationship between the best EP and the presence of CAE was investigated by means of multivariable logistic regression., Results: The rate of CAE in the study population was 32%. On univariable logistic regression, aortic annulus, STJ, STJ-to-SV and STJ-to-AA were associated with the presence of CAE after Bonferroni correction. STJ-to-SV emerged as the parameter with the best discrimination power (AUC = 0.81) compared to STJ (AUC = 0.69), STJ-to-AA (AUC = 0.68), aortic annulus (AUC = 0.59), AA (AUC = 0.56) and SV (AUC = 0.55); (p for comparison <0.01). An 89.6% value for STJ-to-SV ratio emerged as the best cut-off to diagnose CAE with a sensitivity = 75%, specificity = 82%, positive predictive value = 66% and negative predictive value = 88%. On multivariable analysis, STJ-to-SV was still associated with the presence of CAE (OR = 1.15;95%CI:1.11-1.19;p < 0.01)., Conclusion: In patients with dilated aorta, STJ-to-SV sampled by transthoracic echocardiography shows a good diagnostic performance in predicting the presence of CAE., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Although a 1-year duration of dual antiplatelet therapy (DAPT) is used in many patients after drug-eluting stent (DES) implantation, the evidence supporting this duration is uncertain., Objectives: The authors investigated the risk-benefit profile of 1-year vs ≤6-month DAPT after DES using 2 novel scores to risk stratify bleeding and ischemic events., Methods: Ischemic and bleeding risk scores were generated from ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents), a multicenter, international, "all-comers" registry that enrolled 8,665 patients treated with DES. The risk-benefit profile of 1-year vs ≤6-month DAPT was then investigated across risk strata from an individual patient data pooled dataset of 7 randomized trials that enrolled 15,083 patients treated with DES., Results: In the derivation cohort, the ischemic score and the bleeding score had c-indexes of 0.76 and 0.66, respectively, and both were well calibrated. In the pooled dataset, no significant difference was apparent in any ischemic endpoint between 1-year and ≤6-month DAPT, regardless of the risk strata. In the overall dataset, there was no significant difference in the risk of clinically relevant bleeding between 1-year and ≤6-month DAPT; however, among 2,508 patients at increased risk of bleeding, 1-year compared with ≤6-month DAPT was associated with greater bleeding (HR: 2.80; 95% CI: 1.12-7.13) without a reduced risk of ischemic events in any risk strata, including those with acute coronary syndromes. These results were consistent in a network meta-analysis., Conclusions: In the present large-scale study, compared with ≤6-month DAPT, a 1-year duration of DAPT was not associated with reduced adverse ischemic events in any risk strata (including acute coronary syndromes) but was associated with greater bleeding in patients at increased risk of bleeding., Competing Interests: Funding Support and Author Disclosures Dr Palmerini has received speaker fees from Abbott Vascular, Biotronik, and Edwards Lifesciences; and has received a research grant from Eli Lilly. Dr Abizaid is proctor for transcatheter aortic valve replacement for Boston Scientific (Acurate Neo). Dr Valgimigli has received personal fees from AstraZeneca, Alvimedica/CID, Abbott Vascular, Daiichi-Sankyo, Opsens, Bayer, CoreFLOW, Idorsia Pharmaceuticals LTD, Universität Basel Department Klinische Forschung, Vifor, Bristol Myers Squibb SA, iVascular, Medscape, and Biotronik; and has received grants and personal fees from Terumo outside of the submitted work. Dr Morice is a shareholder and CEO of CERC, a CRO not involved in this analysis; and is a minor shareholder of Electroducer, not involved in the study either. Dr Park has received speaker’s fees from Daiichi- Sankyo, AstraZeneca, Sanofi, Bristol Myers Squibb, Bayer, and Pfizer outside of the submitted work. Dr Chieffo has received speaker/consultant fees from Abbott, Abiomed, Biosensor, Cardinal Health, GADA, and Magenta. Dr Nakamura has received grants from Daiichi-Sankyo Co, Ltd, Sanofi K.K., and Bayer K.K.; and has received fees from Daiichi-Sankyo Co, Ltd, Sanofi K.K., Terumo Corporation, Bristol Myers Squibb K.K, and Japan life line Co LTD. Dr Saia has received lecture fees from AstraZeneca, Daiichi-Sankyo, Bayer, and Boehringer Ingelheim. Dr Weisz has received consultation fees from Filterlex, Intratech, and Magenta; and has stock options in Filterlex, Intratech, Magenta, Medivizer, Trisol, and Vectorious. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, and ReCor Medical; in addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting; has received personal consulting fees from Neurotronic; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Mehran has received institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, OrbusNeich, and Zoll; has received consultant fees from Boston Scientific, Cine-Med Research, Janssen Scientific Affairs, and Medscape/WebMD; has received consultant fees paid to the institution from Abbott Laboratories, Abiomed (spouse), Bayer (spouse), Beth Israel Deaconess, Bristol Myers Squibb, CardiaWave, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Spectranetics/Philips/Volcano Corp; has equity <1% from Applied Therapeutics, Elixir Medical, STEL, and CONTROLRAD (spouse); has served as a consultant (no fee) for Regeneron Pharmaceuticals; and has served as Associate Editor for the ACC and AMA. Dr Stone has received speaker or other honoraria from Terumo, Cook, and Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Reva, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus family of funds. No sponsor of any of the individual trials had any role in the study design, data collection, data interpretation, or drafting the manuscript. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

A little is known about long-term hemodynamic performance of the transcatheter heart valves (THVs). The aim of the present study was to assess hemodynamic outcome, structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) in patients treated with transcatheter aortic valve replacement (TAVR) five or more years ago. All consecutive patients treated at Bologna and Florence University Hospitals with TAVR between January 2008 and December 2013 were analyzed in a retrospective registry with regards to demographic, procedural and outcome data as well as follow-up data on mortality and echocardiographic characteristics. Standardized definitions were used to define outcomes and durability of the THVs. 400 patients were included in the study, mostly treated with transfemoral TAVR (71.8%), using first generation balloon-expandable (37%) or self-expanding (63%) devices. The 1-year mortality was 21.8% (87 patients) and 5-year mortality was 53.8% (215 patients). Median follow-up was 45.5 months (14.0-68.9) totaling 1516.7 patient/years, with the longest follow-up being 10.25 years. At least one follow-up echocardiogram was available for 320 patients (80%), SVD occurred in 19 of these patients (5.94%): moderate in 17 patients (5.31%) and severe in two patients (0.63%). The hemodynamic presentation was stenosis in most of the cases (12 patients). Late BVF was registered in 10 patients (3.13%) and this was mainly driven by transcatheter paravalvular leak closure (six patients) with subsequent good long-term outcome. Our results confirm that TAVR appears to be a long-lasting treatment strategy with low rates of structural valve degeneration and valve failure., (© 2021. Società Italiana di Medicina Interna (SIMI).)

Competing Interests: Funding Support and Author Disclosures Dr Saia has received consulting fees from Abbott Vascular, Eli Lilly, AstraZeneca, and St. Jude Medical; and speakers fees from Abbott Vascular, Eli Lilly, AstraZeneca, St. Jude Medical, Terumo, Biosensors, Edwards, and Boston Scientific outside the submitted work. Dr Palmerini has received personal fees from Abbott and Edwards outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Introduction: The optimal choice of oral P2Y12 receptor inhibitors has the potential to significantly influence outcomes. We seek to compare the safety and efficacy of the three most commonly used oral P2Y12 receptor inhibitors (clopidogrel, prasugrel, and ticagrelor) in acute coronary syndromes (ACS) via a comprehensive systematic review and network meta-analysis., Evidence Acquisition: In line with the Preferred Reporting Items for Systematic Reviews (PRISMA) guidelines, we performed a comprehensive search for RCTs which compared cardiovascular and hemorrhagic outcomes after use of at least two of the distinct oral P2Y12 receptor inhibitors (i.e. clopidogrel, prasugrel, and ticagrelor). A search strategy has been designed to systematically search multiple databases, including MEDLINE with PubMed interface, The Cochrane Central Register of Controlled Trials, and Embase. In addition, key inclusion criteria will be trial size of at least 100 patients and at least 1 month of follow-up time. Several prespecified subgroups will be explored, including Asian patients, patients presenting with ST-elevation myocardial infarction, patients of advanced age, and others., Evidence Synthesis: Exploratory frequentist pairwise meta-analyses will be based primarily on a random-effects method, relying on relative risks (RR) for short-term outcomes and incidence rate ratios (IRR) for long-term outcomes. Inferential frequentist network meta-analysis will be based primarily on a random-effects method, relying on RR and IRR as specified above. Results will be reported as point summary of effect, 95% CI, and P values for effect, and graphically represented using forest plots., Conclusions: An international collaborative network meta-analysis has begun to comprehensively analyze the safety and efficacy of prasugrel, ticagrelor and clopidogrel, each on a background of aspirin, for management of patients with ACS. It is our hope that the rigor and breadth of the undertaking described herein will provide novel insights that will inform optimal patient care for patients with ACS treated conservatively, or undergoing revascularization.

Background: Aortic aneurysms are associated with coronary artery ectasia (CAE). However, the relation between the extent of CAE and the severity of aortic dilatation is not understood. This study was undertaken to investigate the relationship between angiographic extension of CAE and aortic dimension., Patients and Methods: We retrospectively include 135 patients with angiographic diagnosis of CAE defined as dilatation of coronary segment more than 1.5 times than an adjacent healthy one. Study population was divided in four groups according to the maximum diameter of ascending aorta beyond sinus of Valsalva obtained in the parasternal long-axis view (group 1: <40 mm; group 2: 40-45 mm; group 3: 45-55 mm; group 4: >55 mm or previous surgery because of aortic aneurysm/dissection). The relationship between aortic dimension and the extension of CAE was investigated by means of multivariable linear regression, including variables selected at univariable analysis (P < 0.1). The total estimated ectatic area (EEA total) was used as dependent variable., Results: Baseline characteristics of study groups were well balanced. Patients in group 4 were more likely to have both higher neutrophil count and neutrophil to lymphocyte ratio. On univariable analysis ascending aorta diameter [Coef. = 0.075; 95% confidence interval (CI) 0.052-0.103, P < 0.01] and c-reactive protein (CRP) values [Coef. = 0.033, 95% CI 0.003-0.174, P = 0.04] showed a linear association with total EEA. After adjustment for CRP values only the ascending aorta diameter was still associated with the extent of CAE (95% CI 0.025-0.063, P < 0.01)., Conclusion: In patients with diagnosis of CAE, a strong linear association between aortic dimension and coronary ectasia extent exists., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: We sought to assess and compare the prediction power of the PRECISE-DAPT and PARIS risk scores with regards to bleeding events in elderly patients suffering from acute coronary syndromes (ACS) and undergoing invasive management., Methods: Our external validation cohort included 1883 patients older >74 years admitted for ACS and treated with PCI from 3 prospective, multicenter trials., Results: After a median follow-up of 365 days, patients in the high-risk categories according to the PRECISE-DAPT score experienced a higher rate of BARC 3-5 bleedings (p = 0.002) while this was not observed for those in the high-risk category according to the PARIS risk score (p = 0.3). Both scores had a moderate discriminative power (c-statistics 0.70 and 0.64, respectively) and calibration was accurate for both risk scores (all χ 2  > 0.05), but PARIS risk score was associated to a greater overestimation of the risk (p = 0.02). Decision curve analysis was in favor of the PRECISE-DAPT score up to a risk threshold of 2%., Conclusions: In the setting of older adults managed invasively for ACS both the PARIS and the PRECISE-DAPT scores were moderately accurate in predicting bleeding risk. However, the use of the PRECISE-DAPT is associated with better performance., Competing Interests: Declaration of Competing Interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to investigate the efficacy and safety of currently used drug-eluting stents (DES)., Background: Head-to-head comparisons among newer DES have shown conflicting results., Methods: For this network meta-analysis, randomized controlled trials comparing different types of currently used DES were searched in PubMed, Scopus, and proceedings of international meetings. The primary endpoint was target lesion failure (TLF) at 1 year and at long-term follow-up., Results: Seventy-seven trials with 99,039 patients were selected for this network meta-analysis. Among the 10 DES included in the meta-analysis, 4 received the most extensive investigation: Orsiro, XIENCE, Nobori/BioMatrix, and Resolute. At 1 year, the Orsiro stent was associated with lower rates of TLF compared with XIENCE (odds ratio [OR]: 0.84; 95% confidence interval [CI]: 0.71 to 0.98; p = 0.03), Resolute (OR: 0.81; 95% CI: 0.68 to 0.95; p = 0.01), and Nobori/BioMatrix (OR: 0.81; 95% CI: 0.67 to 0.98; p = 0.03). Orsiro had the highest probability to be the best (70.8%), with a surface under the cumulative ranking curve value of 95.9%. However, after a median follow-up period of 50 months (range: 24 to 60 months), no significant difference was apparent in the rates of TLF between any DES, although Orsiro still ranked as the best stent (58.6% probability to be the best). In addition, Orsiro had a lower rate of long-term definite stent thrombosis compared with Nobori/BioMatrix (OR: 0.60; 95% CI: 0.36 to 0.98; p = 0.04) and lower rates of definite and probable stent thrombosis compared with Resolute (OR: 0.66; 95% CI: 0.45 to 0.99; p = 0.04). No differences in cardiac mortality between any DES were observed., Conclusions: Orsiro is associated with a lower 1-year rate of TLF compared with XIENCE, Resolute, and Nobori/BioMatrix but with an attenuation of the efficacy signal at long-term follow-up., Competing Interests: Author Disclosures This work was supported by the Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, and by the Fanti Melloni Foundation. Dr. Saia has received personal fees from Abbott Vascular, Eli Lilly, AstraZeneca, Boston Scientific, Medtronic, The Medicines Company, Biotronik, and St. Jude Medical, outside the submitted work. Dr. Palmerini has received speaker fees from Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Recent studies suggest that atrioventricular (AV) conduction may recover after pacemaker (PM) implantation following transcatheter aortic valve replacement (TAVR), but little is known about long-term follow-up of such patients., Objective: The purpose of this study was to evaluate the long-term percentage of right ventricular pacing in patients who underwent TAVR and required PM implantation stratified based on the indication for permanent pacing., Methods: Retrospective analysis of all consecutive patients who underwent TAVR from February 2008 to August 2019 at 3 centers was performed. Patients already implanted with a PM/implantable cardioverter-defibrillator (ICD) before TAVR, implanted with a cardiac resynchronization therapy device, or implanted >30 days after TAVR were excluded. Eligible patients were divided into 2 groups based on the presence (persistent atrioventricular block [AVB] group) or absence (nonpersistent AVB group) of persistent third-degree AVB after TAVR., Results: A total of 1594 patients underwent TAVR. Two hundred four patients were implanted with a PM or ICD after TAVR and 32 met exclusion criteria, so 172 patients were eligible (median time TAVR-PM implant 4 days) for a total of 352 follow-up visits analyzed. A significant difference in the percentage of ventricular pacing was observed at follow-up performed 7-90 days after implantation (98% persistent AVB group vs 8% nonpersistent AVB group; P <.001). This difference remained significant at follow-up performed 91-270 days (95% vs 3.5%; P <.001), 271-540 days (95.5% vs 3%; P = .006), and 541-900 days (97.4% vs 2.2%; P <.001) after implantation., Conclusion: Patients requiring PM implantation due to persistent third-degree AVB after TAVR were less likely to show AV conduction recovery, whereas patients implanted for other indications showed a low percentage of pacing during follow-up., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Incidence and long-term clinical consequences of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) are still unclear., Methods: We enrolled 710 consecutive patients who underwent TAVR. PPM was defined as absent if the index orifice area (iEOA) was >0.85 cm2/m2, moderate if the iEOA was between 0.65 and 0.85 cm2/m2 or severe if the iEOA was <0.65 cm2/m2., Results: Among the 566 patients fulfilling the study criteria, the distribution of PPM was as follows: 50.5% none (n = 286), 43% moderate PPM (n = 243) and 6.5% severe PPM (n = 37). At 5-year follow-up, patients with severe PPM had a significantly higher incidence of the combined endpoint of cardiovascular death, acute myocardial infarction and stroke (p = .025) compared with the other patients. After adjusting the results for possible confounders, severe PPM remained an independent predictor of long-term adverse outcome (HR: 2.46; 95% Confidence Interval: 1.10-5.53). The independent predictors of severe PPM were valve-in-valve procedure and body mass index. Balloon-expandable valves were not associated with higher rates of severe PPM in comparison with self-expandable valves (8% vs. 5%, respectively, p = .245)., Conclusions: In our study severe PPM emerged as a risk factor for long-term major adverse cardiac and cerebrovascular events., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Aims: Conscious sedation instead of general anesthesia has been increasingly adopted in many centers for transfemoral transcatheter aortic valve replacement (TAVR). Improvement of materials and operators' experience and reduction of periprocedural complications allowed procedural simplification and adoption of a minimalist approach. With this study, we sought to assess the feasibility and safety of transfemoral TAVR routinely performed under local anesthesia without on-site anesthesiology support., Methods: The routine transfemoral TAVR protocol adopted at our center includes a minimalist approach, local anesthesia alone with fully awake patient, anesthesiologist available on call but not in the room, and direct transfer to the cardiology ward after the procedure. All consecutive patients undergoing transfemoral TAVR between January 2015 and July 2018 were included. We assessed the rates of actual local anesthesia-only procedures, conversion to conscious sedation or general anesthesia and 30-day clinical outcomes., Results: Among 321 patients, 6 received general anesthesia upfront and 315 (98.1%) local anesthesia only. Mean age of the local anesthesia group was 83.2 ± 6.9 years, Society of Thoracic Surgery score 5.8 ± 4.8%. A balloon-expandable valve was used in 65.7%. Four patients (1.3%) shifted to conscious sedation because of pain or anxiety; 6 patients (1.9%) shifted to general anesthesia because of procedural complications. Hence, local anesthesia alone was possible in 305 patients (96.8% of the intended cohort, 95% of all transfemoral procedures). At 30 days, in the intended local anesthesia group, mortality was 1.6%, stroke 0.6%, major vascular complications 2.6%. Median hospital stay was 4 days (IQR 3-7)., Conclusion: Transfemoral TAVR can be safely performed with local anesthesia alone and without an on-site anesthesiologist in the vast majority of patients.

Introduction: Indications for transcatheter aortic valve replacement (TAVR) are progressively extending to younger and lower risk patients. In this scenario, minimizing periprocedural complications and optimizing procedural result are both crucial to achieve an excellent long-term outcome., Areas Covered: In this review, we summarize the main strategies that can be adopted before, during, and after TAVR to predict and prevent complications, to optimize procedural results and ultimately improve outcomes, with an emphasis on more recent evidence, new devices, and new techniques., Expert Opinion: In the next future TAVR will probably represent the first treatment option for patients affected by aortic valve stenosis who are candidates to receive a biological valve. Continuous refinement of TAVR devices has been key to allow safer and most effective procedures and further progress is expected. Development of new techniques and devices, such as ultrasound-guided puncture and intravascular lithotripsy, will expand safety and eligibility to transfemoral procedures. Effective preemptive measures for coronary occlusion have been developed. Open issues include cerebral protection, re-access to coronary arteries, post-procedural management, and therapy.

This study sought to investigate the impact of elective, uncomplicated target lesion revascularization (TLR) on long-term cardiac mortality after percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) disease. Consecutive patients undergoing PCI for ULMCA disease between January 2003 and December 2015 in 1 interventional center in Northern Italy were included. Patients presenting with cardiogenic shock, ST-segment elevation myocardial infarction (MI), as well as those undergoing urgent or complicated TLR were excluded. The primary endpoint of the study was cardiac mortality. Among the 418 patients fulfilling the study criteria, 79 (18.46%) underwent elective, uncomplicated TLR. After a median follow-up of 5.5 years, there were 23 cardiac deaths among patients undergoing elective, uncomplicated TLR versus 50 in patients not undergoing TLR. After adjusting for possible confounders, TLR was an independent predictor of cardiac mortality (Hazard ratio [HZ] = 1.92, 95% confidence interval [CI]: 1.05 to 3.49; p = 0.03). Patients undergoing TLR had also significantly higher rates of the composite of cardiac death, MI and stroke compared with the no TLR group (adjusted HR = 1.76, 95% CI 1.14 to 2.72). In conclusion, elective, uncomplicated TLR after PCI of ULMCA disease is associated with increased risk of long-term cardiac mortality. Reducing the risk of TLR after PCI of ULMCA disease may potentially improve the survival of these patients., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: To assess whether coronary bypass (CABG) or stenting reduce the risk of mortality and myocardial infarction (MI) compared with optimal medical therapy (OMT) in stable coronary artery disease (CAD)., Methods: We performed a systematic review and network meta-analysis of contemporary randomized controlled trials comparing OMT, CABG and different stent types in stable CAD. All-comer trials were included if the rate of patients with acute myocardial infarction (AMI) was≤20%. Endpoints were all-cause mortality and MI., Results: Ninety-seven trials including 75,754 patients were analyzed at a weighted mean follow up of 42.5 months. Compared to OMT, CABG was associated with a lower risk of death (OR = 0.84; 95%CI:0.71-0.97). After exclusion of trials in left main and/or multivessel disease(LM/MVD) this benefit was not statistically significant (OR = 0.89; 95%CI:0.74-1.06). CABG was associated with a lower risk of MI (OR = 0.67;95%CI: 0.49-0.91) showing, however, a certain degree of inconsistency (p=0.10). None of the stent types included was associated with a lower risk of death. However, durable-polymer-CoCr-everolimus-eluting stent, by mixed evidence, after exclusion of either LM/MVD (OR = 0.73;95%CI: 0.54-0.98) or all-comer/post-MI trials (OR = 0.62;95%CI:0.39-0.98) was associated with a lower risk of MI than OMT. Similar findings, by indirect evidence, were confirmed for bio-absorbable-polymer-CoCr-sirolimus eluting stent (LMV/MVD trials excluded OR = 0.46; 95%CI = 0.29-0.74, all-comer/post-MI trials excluded: OR = 0.41;95%CI:0.22-0.79)., Conclusions: In stable CAD, CABG reduces the risk of mortality and MI compared to OMT, especially in patients with higher extent of CAD. Our study suggests that some of second and latest-generation drug-eluting stents may reduce the risk of MI. Future research should confirm these latter findings., Competing Interests: Declaration of competing interest The authors report no relationships that could be construed as a conflict of interest., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR)., Background: Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality., Methods: Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019., Results: Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19)., Conclusions: In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system., Methods and Results: The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4±8.3 years, average STS score 3.8±2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%., Conclusions: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.

Background: The majority of stent-related major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI) are believed to occur within the first year. Very-late (>1-year) stent-related MACE have not been well described., Objectives: The purpose of this study was to assess the frequency and predictors of very-late stent-related events or MACE by stent type., Methods: Individual patient data from 19 prospective, randomized metallic stent trials maintained at a leading academic research organization were pooled. Very-late MACE (a composite of cardiac death, myocardial infarction [MI], or ischemia-driven target lesion revascularization [ID-TLR]), and target lesion failure (cardiac death, target-vessel MI, or ID-TLR) were assessed within year 1 and between 1 and 5 years after PCI with bare-metal stents (BMS), first-generation drug-eluting stents (DES1) and second-generation drug-eluting stents (DES2). A network meta-analysis was performed to evaluate direct and indirect comparisons., Results: Among 25,032 total patients, 3,718, 7,934, and 13,380 were treated with BMS, DES1, and DES2, respectively. MACE rates within 1 year after PCI were progressively lower after treatment with BMS versus DES1 versus DES2 (17.9% vs. 8.2% vs. 5.1%, respectively, p < 0.0001). Between years 1 and 5, very-late MACE occurred in 9.4% of patients (including 2.9% cardiac death, 3.1% MI, and 5.1% ID-TLR). Very-late MACE occurred in 9.7%, 11.0%, and 8.3% of patients treated with BMS, DES1, and DES2, respectively (p < 0.0001), linearly increasing between 1 and 5 years. Similar findings were observed for target lesion failure in 19,578 patients from 12 trials. Findings were confirmed in the network meta-analysis., Conclusions: In this large-scale, individual patient data pooled study, very-late stent-related events occurred between 1 and 5 years after PCI at a rate of ∼2%/year with all stent types, with no plateau evident. New approaches are required to improve long-term outcomes after PCI., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: We sought to investigate the thrombogenicity of different DES and BMS in an in vitro system of stent perfusion., Material and Methods: The experimental model consisted of a peristaltic pump connected to 4 parallel silicone tubes in which different stents were deployed. Blood was drawn from healthy volunteers and the amount of stent surfaced-induced thrombus deposition was determined using 125 I-fibrinogen., Results: Compared to Resolute, Biomatrix and Vision, Xience was associated with the lowest amount of stent surface-induced thrombus formation, with a significant difference compared to Vision ( 125 I-fibrinogen median value deposition [IQ range]: 50 ng [25-98] versus 560 ng [320-1520], respectively, p < 0.05), but not to other DES. In the second set of experiments Fluoropolymer-coated BMS not eluting drug was associated with a significant 3-fold reduction in 125 I-fibrinogen deposition (245 ng [80-300]) compared to Vision (625 ng [320-760], p < 0.05), but a 7-fold increase compared to Xience (35 ng [20-60], p < 0.05). Finally Xience was associated with a significantly greater absorption of albumin compared to BMS., Conclusions: In an in vitro system of stent perfusion, Xience was associated with the lowest amount of stent surface-induced thrombus formation compared with Resolute, Biomatrix and Vision, with a noted synergistic effect between the fluoropolymer and the drug., (Copyright © 2019 Elsevier Ltd. All rights reserved.)