Search

Background: The incidence and prognostic impact of major bleeding (MB) after percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) are unknown., Objectives: The goal of this study was to investigate the rates and outcomes of MB after LMCAD revascularization., Methods: In the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with unprotected LMCAD were randomized to undergo PCI (n = 948) or CABG (n = 957) and followed up for 5 years. MB was defined as TIMI major or minor bleeding, BARC (Bleeding Academic Research Consortium) types 3 to 5 bleeding, or any overt bleeding requiring blood transfusion. The association between MB and subsequent mortality was assessed in time-adjusted Cox regression models., Results: At 5 years, 217 patients (11.4%) had at least 1 MB event. Rates of 5-year MB were 7.9% after PCI vs 14.8% after CABG (OR: 0.48; 95% CI: 0.36-0.65; P < 0.0001). However, in-hospital MB was lower after PCI (3.8% vs 13.5%; OR: 0.25; 95% CI: 0.17-0.37), whereas postdischarge MB was lower after CABG (4.5% vs 2.0%; OR: 2.33; 95% CI: 1.33-3.09; P interaction < 0.0001). All 41 postdischarge MB events after PCI occurred in patients receiving dual antiplatelet therapy. MB events within 5 years were associated with a higher subsequent risk of all-cause mortality (adjusted HR: 2.71; 95% CI: 1.95-3.77; P < 0.0001), whether in-hospital or postdischarge (P interaction  = 1.00) and after both PCI and CABG (P interaction  = 0.95), driven both by increased cardiovascular and non-cardiovascular mortality., Conclusions: In the EXCEL trial, CABG resulted in higher 5-year rates of all MB and in-hospital MB, although postdischarge MB was more frequent after PCI. MB after both procedures was associated with increased cardiovascular and noncardiovascular mortality within 5 years. (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)., Competing Interests: Funding Support and Author Disclosures The EXCEL trial was funded by Abbott Vascular. Dr Giustino is a consultant and proctor for Edwards Lifesciences. Dr Sabik has served as a consultant for Medtronic, Edwards, and Sorin; and has served on the advisory board for Medtronic Cardiac Surgery. Dr Serruys has served as a consultant for Abbott, Biosensors, Medtronic, Micell Technologies, SINOMED, Philips/Volcano, Xeltis, and HeartFlow. Dr Kandzari has received consulting honoraria and research/grant support from Medtronic, Biotronik, and Boston Scientific. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi-Sankyo, Ablative Solutions, CorFlow, CardioMech, Robocath, Miracor, Vectorious, Apollo Therapeutics, Elucid Bio, VALFIX, TherOx, HeartFlow, Neovasc, Ancora, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, HighLife, and Elixir; and has equity/options from Ancora, Cagent, Applied Therapeutics, BioStar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, VALFIX, and Xenter. Dr Stone’s employer, Mount Sinai Hospital, receives research grants from Abbott, Abiomed, BioVentrix, Cardiovascular Systems Inc, Philips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-Wave. 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.)

Introduction: Stroke is now the 5th leading cause of death in the United States, and carotid artery stenosis is the cause of about 20% to 25% of strokes. We hypothesized that CAS may be an alternative to CEA in both symptomatic and asymptomatic patients with carotid artery stenosis., Methods: We evaluated the clinical characteristics, adverse events and mortality of patients with carotid artery stenosis comparing CEA vs. CAS using data from a national population-based cohort study from January 1, 2016, to December 30, 2020., Results: We evaluated 374,875 patients with carotid stenosis, of whom 344,020 had asymptomatic carotid stenosis and 30,855 had symptomatic carotid stenosis. CAS was associated with higher mortality in both symptomatic and asymptomatic carotid stenosis, compared to CEA, with the trend slightly decreasing for both interventions from the years 2018-2020. CEA was associated with lower adverse events in both symptomatic and asymptomatic carotid stenosis, compared to CAS., Conclusions: Our current data suggest a benefit of CEA over CAS for both symptomatic and asymptomatic carotid stenosis with lower complications, lower mortality and a higher rate of discharge. However, this is not a head-to-head comparison as it becomes selection bias for this procedure; therefore, further prospective head-to-head comparison between 2 groups in the same patient population is needed., Competing Interests: Declaration of competing interest The authors 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: Systemic inflammatory response syndrome (SIRS) following cardiovascular interventions is associated with adverse events during hospitalization and follow-up. Mitral transcatheter edge-to-edge repair is increasingly utilized for treatment of mitral regurgitation (MR). We investigated whether SIRS following mitral transcatheter edge-to-edge repair may occur and be associated with adverse clinical outcomes., Methods and Results: A total of 158 consecutive patients with severe MR undergoing mitral transcatheter edge-to-edge repair were studied. SIRS was defined by leukocytosis (≥12 × 10 9 /L) and fever (≥38 °C) within 48 hours after intervention. Baseline inflammation was measured by absolute neutrophil and lymphocyte counts and neutrophil-lymphocyte ratio. The primary end point of major cardiovascular events was the composite of nonfatal myocardial infarction, nonfatal stroke, and all-cause death. Recurrent MR at follow-up was also recorded. The mean patient age was 80.8±8.8 years. Forty-four (27.9%) developed SIRS. Neutrophil-lymphocyte ratio correlated with onset of leukocytosis and fever ( P =0.04). During a median follow-up of 12.5 (5.4-17.4) months, the primary end point occurred in 27 (17.1%) patients (6 myocardial infarction, 5 strokes, and 16 deaths). Patients with SIRS more often had severe MR (79.5% versus 62.7%, P =0.02) at follow-up. After adjustment for pertinent variables, SIRS (HR 2.73 [95% CI, 1.08-6.86]; P =0.03) was independently associated with major cardiovascular events., Conclusions: SIRS after mitral transcatheter edge-to-edge repair is a strong independent predictor of major cardiovascular events. Closer follow-up is warranted because patients with SIRS have more severe MR at follow-up.

Limited evidence exists concerning the prognostic impact of baseline left ventricular ejection fraction (LVEF) on outcomes among women undergoing transcatheter aortic valve implantation (TAVI), which we aimed to investigate in the present analysis. Patients from the Women's International Transcatheter Aortic Valve Implantation (WIN-TAVI) registry were categorized according to baseline LVEF into 3 groups: reduced (LVEF ≤40%), mildly reduced (LVEF between 41% and 49%), and preserved (LVEF ≥50%) LVEF. The primary (Valve Academic Research Consortium 2 [VARC-2]) efficacy point was defined as a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure, or valve-related dysfunction at 1 year. The primary (VARC-2) safety end point included all-cause mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 to 3 acute kidney injury, coronary artery obstruction requiring intervention, or valve-related dysfunction requiring repeated procedures. A Cox regression model was performed using the preserved LVEF group as the reference. Among the 944 patients included, 764 (80.9%) exhibited preserved, 80 (8.5%) had mildly reduced, and 100 (10.6%) had reduced LVEF. The 1-year incidence of VARC-2 efficacy end point was numerically higher in patients with reduced LVEF, albeit not resulting in a significant risk difference. Notably, reduced LVEF was associated with a higher risk of the 1-year VARC-2 safety end point, still significant after adjustment (28.0% vs 19.6%, Hazard Ratio 1.78, 95% Confidence Interval 1.12- 2.82, p = 0.014). These differences were primarily driven by trends toward increased rates of all-cause mortality, cardiovascular mortality, and major vascular complications. Clinical outcomes were similar between patients with mildly reduced and preserved LVEF. In conclusion, when performed in women with reduced LVEF, TAVI was associated with a worse (VARC-2) safety profile at 1-year follow-up. In contrast, patients with mildly reduced LVEF appeared to align more closely with outcomes observed in the preserved LVEF group than with the reduced LVEF group., Competing Interests: Declaration of competing interest Dr. Bay is supported by a grant from the German Heart Foundation, grant no. S/06/23. Dr. Petronio received consultancy fees from Medtronic, Abbott, and Boston and funds from Boston and Abbott. Dr. Mehilli received institutional grants from Boston Scientific and lecture fees from AstraZeneca, Bristol-Myers Squibb, Boston Scientific, and Edwards Lifesciences. Dr. Lefèvre proctors for Edwards, Boston, and Abbott. Dr. Sardella received sponsorships from Medtronic in terms of technical training courses and congress assistance. Dr. Van Mieghem received research grant support and advisory fees from Abbott, Boston Scientific, and Medtronic, and research grant support from Edwards Lifesciences. Dr. Dumonteil received proctoring and consultancy fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Mikhail is the Director of Imperial Valve and Cardiovascular Course, which is supported by several device and pharmaceutical companies; he has received an educational grant from Abbott for an Interventional Fellowship. Dr. Ferrer-Gracia received sponsorships from Medtronic and Edwards companies in terms of technical training courses and congress assistance. Dr. Sharma served on the Speakers Bureau of Abbott Vascular, Boston Scientific, and Cardiovascular Systems, Inc. Dr. Morice is CEO and shareholder of CERC, a CRO based in Massy that had no role in WIN-TAVI. Dr. Dangas received consulting fees from GE Healthcare, Janssen Pharmaceuticals, Inc., and Medtronic, Inc.; <1% equity with Claret Medical and Elixir Medical; delivered industry-sponsored lectures for The Medicines Company; and is on the Scientific Advisory Board of AstraZeneca. Dr. Chieffo received speaker/consultant fees from Abiomed, Abbott Vascular, Biosensor, Cardinal Health, GADA, and Magenta Medical. Dr. Mehran received research grants to the institution from Abbott, Abiomed, Alleviant Medical, AM-Pharma, Amgen, Applied Therapeutics, Arena, AstraZeneca, BAIM, Bayer, Beth Israel Deaconess, Biosensors, Biotronik, Boston Scientific, Bris- tol-Myers Squibb, CardiaWave, CellAegis, CeloNova, CERC, Chiesi, Concept Medical, CSL Behring, Cytosorb- ents, DSI, Duke University, Element Science, Faraday, Humacyte, Idorsia, Insel Gruppe AG, Magenta, Medtronic, Novartis, OrbusNeich, PhaseBio, Philips, RenalPro, Shock- wave, Vivasure, and Zoll and consulting fees from Cine-Med Research, WebMD. The authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) has undergone significant advances in recent years, with the development of improved pre-planning tools and devices. These advances have led to a reduction in the rate of paravalvular leak (PVL), a complication that is associated with poor outcomes even when mild. As some centers around the world are moving to solely fluoroscopy-focused implantation, we aimed to describe the clinical impact of intra-procedural transthoracic echocardiography (TTE) during TAVI in a high volume hospital., Methods: Observational study during a 3-month period. A limited TTE examination was performed immediately after deployment to assess the existence of PVL and grade its severity. Complete TTE was performed a day after the procedure. In case of ≥mild PVL after valve deployment, a decision was made according to the severity of the PVL, patient anatomy and extent of annular calcification to preform balloon post-dilation. If done, an additional limited TTE was performed to assess possible complication and the degree of PVL post dilatation., Results: 115 patient were included in the study. Intra-procedural TTE identified 16 patients (14 %) with at least mild PVL, three of them with moderate (3 %). Post balloon dilatation was performed in 10 patients (9 % of the cohort) with significant improvement in the degree of PVL., Conclusion: Intra-procedural TTE immediately after TAVI deployment can accurately identify PVL, allowing operators to perform post balloon dilatation with improvement in early echocardiographic results. Our findings support the routine use of TTE during procedures, without relying solely on fluoroscopy., Competing Interests: Declaration of competing interest The authors 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: The optimal treatment strategy for coronary calcified nodules (CN) remains uncertain. We aimed to evaluate the efficacy and safety of different calcium modification strategies, including rotational atherectomy (RA), orbital atherectomy (OA), and intravascular lithotripsy (IVL) for managing CN with optical coherence tomography (OCT) guidance., Methods: Consecutive patients undergoing OCT-guided percutaneous coronary intervention (PCI) for severely calcified lesions using RA, OA, or IVL between January 2017 and December 2022 were included. Primary endpoint was minimum stent area (MSA) post-PCI. Secondary endpoints included MSA at CN site and 1-year target vessel failure (TVF), defined as a composite of cardiac death, target-vessel myocardial infarction, or target vessel revascularization., Results: Among 154 patients and 158 lesions, CN was identified in 54 lesions (34.2%) and managed with RA (39%, n = 21), OA (33%, n = 18), or IVL (28%, n = 15). The IVL group exhibited a larger minimal lumen diameter, maximum calcium arc, and maximum calcium thickness. Post-PCI OCT demonstrated comparable MSA (RA: 6.23 ± 0.34 mm², OA: 5.75 ± 0.39 mm², IVL: 6.24 ± 0.46 mm²; p = 0.62) and MSA at CN site (7.17 ± 0.43 mm², 6.46 ± 0.49 mm², 7.86 ± 0.56 mm², respectively; p = 0.55) after adjusting for morphologic factors. The incidence of TVF at 1 year was similar among the group (RA: 19.0%, OA: 22.2%, IVL: 13.3%, p = 0.81)., Conclusions: In patients undergoing PCI for CN, similar procedural and clinical outcomes can be achieved using RA, OA, or IVL. These findings warrant further investigation in larger, prospective trials., (© 2024 Wiley Periodicals LLC.)

Aims: In standard time-to-first event analysis, early aspirin discontinuation followed by ticagrelor monotherapy has been shown to reduce bleeding without increasing ischemic complications compared with ticagrelor plus aspirin after percutaneous coronary intervention (PCI). We evaluated whether these treatment effects are preserved when recurrent events are considered., Methods and Results: In this TWILIGHT trial post hoc analysis, we assessed the effects of ticagrelor monotherapy on the total number of events that occurred over the 12-month follow-up among 7 119 high-risk patients randomized to aspirin or placebo in addition to ticagrelor at 3 months post-PCI if event-free and adherent to treatment. There were 391 patients with at least one Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding (primary endpoint). Of those, 28 (7.2%) had a recurrent event. The total number of BARC 2, 3, or 5 bleeding events were 148 in the ticagrelor monotherapy arm compared with 278 with ticagrelor plus aspirin arm (p < 0.001). Among 272 patients with at least one key secondary ischemic endpoint (all-cause death, myocardial infarction, or stroke), 37 (13.6%) sustained a recurrent event. Total ischemic events were similar (155 vs 159) in the two groups., Conclusions: Among selected high-risk patients who underwent PCI and completed 3 months of dual antiplatelet therapy followed by ticagrelor with or without aspirin, recurrent bleeding was less common than recurrent ischemic events over 12 months. Analysis of total events indicates that ticagrelor monotherapy continues to be more effective than ticagrelor plus aspirin in reducing bleeding without a signal of ischemic harm., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objectives: We aim to describe the step-by-step optical coherence tomography-guided rotational atherectomy and intravascular lithotripsy for treating substantial coronary calcified nodules., Key Steps: These include initial rotational atherectomy with a 1.5-mm burr, multiple optical coherence tomography imaging studies to assess lesion morphology, upsizing the rotational burr to 2.0 mm for further debulking, performing adjunctive intravascular lithotripsy with a 3.5-mm Shockwave balloon (Shockwave Medical Inc), and final stent deployment and optimization., Potential Pitfalls: Potential complications include burr entrapment during rotational atherectomy, inadequate lesion modification with initial rotational atherectomy, and failure to achieve deep calcium fractures leading to stent underexpansion. To avoid these complications, start with a smaller burr size and use a slow pecking motion, conduct a meticulous intravascular imaging assessment, and upsize the burr and adjunctive intravascular lithotripsy on the basis of intravascular imaging findings., Take-Home Messages: Detailed intravascular imaging is crucial for guiding personalized treatment strategies. Combining rotational atherectomy and intravascular lithotripsy (RotaTripsy) provides a synergistic approach for treating extensive calcified nodules., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Secondary mitral regurgitation (SMR) is associated with increased mortality and heart failure hospitalizations. The management of heart failure patients with SMR is complex and requires a multidisciplinary Heart Team approach. Guideline-directed medical therapies remain fundamental, yet in a proportion of patients SMR persists. In the past decade, transcatheter edge-to-edge repair (TEER) has been shown to improve survival in patients with SMR who remain symptomatic despite medical therapy. Technical advancements across newer generations of devices, improved imaging, and greater operator expertise have collectively contributed to the increased safety and efficacy of this procedure over time. Various emerging transcatheter mitral valve repair and replacement devices are currently under investigation and may offer superior, complementary or synergistic treatment options in patients ineligible for TEER. This review provides a state-of-the-art overview regarding the diagnosis of SMR, and currently available transcatheter mitral valve interventions and describes a contemporary approach to the management of SMR., Competing Interests: Conflicts of interest statement Dr. Safi is a speaker for Medtronic and Abbott. Dr. Tang has received speaker's honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member and IMPACT MR steering committee member for Medtronic, has received speaker's honoraria and served as a physician proctor, consultant, advisory board member and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart, has served as an advisory board member for Boston Scientific and JenaValve, a consultant for NeoChord, Shockwave Medical, Peija Medical and Shenqi Medical Technology, and has received speaker's honoraria from Siemens Healthineers. Dr. Sharma has received speaker's bureau fees from Abbott Vascular, Boston Scientific, and Cardiovascular Systems. Dr. Khera is a consultant and proctor for Medtronic, consultant and proctor for Abbott Structural Heart, consultant for Terumo and W. L. Gore & Associates, consultant and advisory board member of EastEnd Medical, and serves on the speaker's bureau for Zoll Medical and Edwards Lifesciences. Dr. Pinney reports receiving consulting fees from: Abbott, ADI, Ancora, BMS, CareDx, Cordio, Impulse Dynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, Valgen Medtech. The remaining authors have nothing to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Calcific coronary artery stenosis is a complex disease associated with adverse outcomes and suboptimal percutaneous treatment. Calcium plaque modification has emerged as a key strategy to tackle the issues that accompany calcific stenosis - namely reduced device deliverability, unpredictable lesion characteristics, and difficult dilatation. Atherectomy has traditionally been the treatment modality of choice for heavily calcified coronary stenoses. Contemporary technologies have emerged to aid with planning, preparation, and treatment of calcified coronary stenosis in an attempt to improve procedural success and long-term outcomes. In this State Of The Art Review, we synthesize the body of data surrounding the diagnosis, imaging, and treatment of calcific coronary disease, with a focus on i) intravascular imaging, ii) calcific lesion preparation, iii) treatment modalities including atherectomy, and iv) updated treatment algorithms for the management of calcified coronary stenosis., Competing Interests: Declaration of competing interest None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Low-flow (LF) aortic stenosis (AS) is common among older adults and associated with worse outcomes than AS with normal stroke volume. It is unknown whether left ventricular (LV) remodeling identifies patients with LF AS at higher risk of complications. LV remodeling was evaluated in 463 patients with severe LF AS referred for transcatheter aortic valve replacement (TAVR) and classified as adaptive (normal geometry and concentric remodeling) or maladaptive (concentric and eccentric hypertrophy) using the American Society of Echocardiography gender-specific criteria. Of these, the 390 patients who underwent TAVR were followed for the end points of heart failure (HF) hospitalization and all-cause mortality. The mean patient age was 79 (74.5 to 84) years. LV remodeling was adaptive in 57.4% (62 normal geometry, 162 concentric remodeling) and maladaptive in 42.6% (127 concentric hypertrophy, 39 eccentric hypertrophy). During a median follow-up of 3 years, 45 patients (11.5%) were hospitalized for HF and 73 (18.7%) died. After adjustment for widely used echocardiographic parameters, maladaptive remodeling was independently associated with HF hospitalization and death (adjusted hazard ratio 1.75, confidence interval 1.03 to 3.00). There was no significant difference between men and women in the association of maladaptive LV remodeling with the composite outcome (p = 0.40 for men and p = 0.06 for women). In conclusion, in patients with LF AS, maladaptive LV remodeling before TAVR is independently associated with higher incidences of postprocedural HF rehospitalization and death in both men and women. Assessment of LV remodeling has prognostic value over and above LV ejection fraction and may improve risk stratification for patients with LF AS., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

We report the case of an 80-year-old woman with known quadricuspid aortic valve (QAV), severe aortic stenosis, and moderate-to-severe regurgitation who recently underwent a transcatheter aortic valve replacement (TAVR).

Background: It remains unclear whether procedural myocardial infarction (pMI) and spontaneous myocardial infarction (spMI) have a similar impact on prognosis., Objectives: The aim of this study was to assess mortality after pMI and spMI., Methods: Patients with chronic coronary syndrome (CCS) and baseline troponin ≤1× the upper reference level (URL) or with acute spMI who underwent percutaneous coronary intervention (PCI) were included. PMI was defined as post-PCI troponin increase >1× URL in patients with CCS. SpMI comprised any acute coronary syndrome with elevated troponin. The 1-year risk of all-cause death was assessed after pMI and spMI across 3 strata of troponin elevation (>1-5×, >5-35×, and >35× URL), with CCS patients having post-PCI troponin ≤1× URL as a reference group. Conventional troponin I was measured using the Architect methodology (Abbott)., Results: Among 10,707 patients undergoing PCI from 2012 to 2020, 8,515 patients presented with CCS and 2,192 with spMI. Among CCS patients, 913 (10.7%) had pMI. Troponin peaks >1-5×, >5-35×, and >35× URL were observed in 53%, 41%, and 6% of patients with pMI, and in 24%, 38%, and 37% of patients with spMI, respectively. Mortality at 1 year was higher after pMI (7.7%; adjusted HR: 4.40; 95% CI: 1.59-12.2), and spMI (8.5%; adjusted HR: 7.57; 95% CI: 5.44-10.5) with troponin peak >35× URL compared with no-MI (1.4%). Mortality was also increased after spMI with troponin peak >1-5× or >5-35× URL., Conclusions: Mortality at 1 year was significantly increased after pMI and spMI with troponin peak >35× URL, whereas for troponin levels ≤35× only spMI had a relevant impact on mortality., Competing Interests: Funding Support and Author Disclosures Dr Spirito has received a research grant from the Swiss National Science Foundation. Dr Baber has received honoraria from AstraZeneca and Boston Scientific. Dr Khera has received consulting or speaker fees from Medtronic, Edwards Lifesciences, Abbott Structural Heart, Eastend Medical, Terumo, Zoll Medical, and W.L.Gore & Associates; has served as a proctor for Medtronic and Abbott Structural Heart; and is also global principal investigator of a study funded by Teleflex (no compensation). Dr Windecker has received research, travel, or educational grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Farapulse Inc, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson & Johnson, Medalliance, Medicure, Medtronic, Merck Sharp & Dohm, Miracor Medical, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave, with payments to the institution but no personal payments; and is also a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Dangas has received consulting fees and advisory board fees from AstraZeneca; has received consulting fees from Biosensors; and previously held stock in Medtronic. Dr Mehran has received institutional research grants from Abbott, Affluent Medical, Alleviant Medical, Amgen, AstraZeneca, Boston Scientific, Bristol Myers Squibb, CardiaWave, CERC, Chiesi, Concept Medical, Daiichi-Sankyo, Duke, Faraday, Idorsia, Janssen, MedAlliance, Medscape, Mediasphere, Medtelligence, Medtronic, Novartis, OrbusNeich, Pi-Cardia, Protembis, RM Global Bioaccess Fund Management, Sanofi, and Zoll; has received consulting fees from Affluent Medical, Boehringer Ingelheim, Chiesi USA, Cordis, Daiichi-Sankyo, Esperion Science/Innovative Biopharma, Gaffney Events, Educational Trust, Global Clinical Trial Partners, Ltd, IQVIA, Medscape/WebMD Global, NovoNordisk, PeerView Institute for Medical Education, TERUMO Europe N.V., and Radcliffe; has equity <1% in Elixir Medical, STEL, and CONTROLRAD (spouse); has received honorarium for serving om the Scientific Advisory Board for AMA, JAMA Cardiology (Associate Editor), and the American College of Cardiology; and is a Committe Member for SCAI, Faculty member of the Cardiovascular Research Foundation, and founder of Women as One (no fee). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: High-risk percutaneous coronary interventions (HRPCI) are a potential treatment option for patients with reduced left ventricular ejection fraction (LVEF) and coronary artery disease. The extent to which such intervention is coupled with improvement in LVEF and associated with favorable outcomes is unknown., Methods: We aimed to characterize the incidence and correlates of LVEF improvement after Impella-guided HRPCI, and compare clinical outcomes in patients with versus without LVEF improvement. Data on consecutive patients undergoing Impella-guided HRPCI from a single center registry were analyzed. LVEF-improvement was defined as an absolute increase of LVEF of ≥10% measured at ≥30-days after intervention. The primary outcome was a composite of all-cause death, myocardial infarction or target vessel revascularization within 1-year., Results: Out of 161 consecutive patients undergoing Impella-guided HRPCI from June 2008 to December 2017, 43% ( n  = 70) demonstrated LVEF-improvement (baseline LVEF of 25.09 ± 6.19 to 33.30 ± 11.98 post intervention). Patients without LVEF-improvement had higher frequency of previous MI (61.5% vs. 37.1%, p  = 0.0021), Q-waves on ECG (17.6% vs. 5.7%, p  = 0.024) and higher SYNTAX scores (30.8 ± 17.6 vs. 25.2 ± 12.2; p  = 0.043). After correction of these confounders by multivariable analysis, no significant differences were found regarding the composite endpoint in patients with versus without LVEF-improvement (34.9% vs. 38.3%; p  = 0.48)., Discussion: In this single-center retrospective analysis, we report the following findings. First, LVEF improvement of at least 10% was documented in over 40% of patients undergoing Impella supported high-risk PCI. Second, a history of MI, Q-waves on admission ECG, and higher baseline SYNTAX scores were independent correlates of no LVEF improvement. Third, one year rates of adverse CV events were substantial and did not vary by the presence or absence of LVEF improvement Prospective studies with longer follow-up are needed to elucidate the impact of LVEF improvement on clinical outcomes., Competing Interests: GD has received consulting fees and honoraria from Johnson & Johnson, Sanofi, Covidien, The Medicines Company, Merck, CSL Behring, AstraZeneca, Medtronic, Abbott, Bayer, Boston Scientific, Osprey Medical, and GE Healthcare; and research grant support from Sanofi, Bristol-Myers Squibb, and Eli Lilly & Company/Daiichi-Sankyo. RM has received institutional research grant support from Eli Lilly, AstraZeneca, The Medicines Company, BMS/Sanofi-Aventis, consulting fees from AstraZeneca, Bayer, CSL Behring, Janssen Pharmaceuticals Inc., Merck & Co., Osprey Medical Inc., Watermark Research Partners. She also serves as a Scientific Advisory Board member for Abbott Laboratories, Boston Scientific Corporation, Covidien, Janssen Pharmaceuticals, The Medicines Company and Sanofi-Aventis. SS has received speakers honorarium from Abbott vascular Inc., Boston, Scientific Corporation, Cardiovascular Systems, Inc. (CSI). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Farhan, Freilich, Giustino, Vogel, Baber, Sartori, Kamran, Mehran, Dangas, Krishnan, Kini and Sharma.)

Percutaneous coronary intervention (PCI) has demonstrated its safety and efficacy in treating left main (LM) coronary artery disease (CAD) in select patients. Polyvascular disease (PolyVD) is associated with adverse events in all-comers with CAD. However, there is little data examining the interplay between PolyVD and LM-PCI, which we sought to investigate in a retrospective single-center study. We included patients who underwent unprotected LM-PCI at a tertiary center from 2012 to 2019. The study population was stratified based on the presence or absence of PolyVD (i.e., medical history of cerebrovascular and/or peripheral artery disease in addition to LM-CAD). The primary outcome was major adverse cardiovascular events (MACE) combining all-cause mortality and spontaneous myocardial infarction within 1 year after index PCI. Overall, 869 patients were included, and 23.8% of the population had PolyVD. Subjects with PolyVD were older and had a greater burden of co-morbidities. After 1-year follow-up, PolyVD patients exhibited significantly higher rates of both MACE (22.8% vs 9.4%, p <0.001) and bleeding events compared with those without PolyVD. MACE was primarily driven by an increase in all-cause mortality (18.3% vs 7.1%, p <0.001). Results persisted after adjusting for confounders. In conclusion, in patients who underwent LM-PCI, the presence of PolyVD is linked to an increased risk of MACE and bleeding after 1 year of follow-up, which highlights the vulnerability of this population., Competing Interests: Declaration of competing interest Dr. Dangas received research grants from institutions and support for attending meetings from Daiichi Sankyo. Dr. Mehran reports institutional research payments from: Abbott, Abiomed, Affluent Medical, Alleviant Medical, Amgen, AM-Pharmacia, Arena, AstraZeneca, AtriCure Inc., Biosensors, Biotronik, Boston Scientific, Bristol-Myers Squibb, CardiaWave, CeloNova, CERC, Chiesi, Concept Medical, Cytosorbents, Daiichi Sankyo, Duke, Element Science, Essential Medical, Faraday, Idorsia Pharmaceuticals, Janssen, MedAlliance, Mediasphere, Medtelligence, Medtronic, MJH Healthcare, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, PLx Pharma, Population Health Research Institute, Protembis, RecCor Medical Inc., RenalPro, RM Global, Sanofi, Shockwave, Vivasure, Zoll; Personal fees from: Affluent Medical, Cardiovascular Research Foundation (CRF), Cordis, Daiichi Sankyo Brasil, E.R. Squibb & Sons Science/Innovative BioPharma, Europa Group/Boston Scientific, Gaffney Events, Educational Trust, Henry Ford Health Cardiology, Ionis Pharmaceuticals, MedCon International, Novartis, NovoNordisk, PeerView Institute for Medical Education, Terumo Europe N.V., Vectura, VoxMedia, WebMD, IQVIA, Radcliffe, tarsus Cardiology; No Fees from: AMA (Scientific Advisory Board), SCAI (Women in Innovations Committee Member); Faculty CRF; Honorarium: JAMA Cardiology (Associate Editor), ACC (BOT Member, SC Member CTR Program); Equity <1% in: applied Therapeutics, Elixir Medical, Stel, ControlRad (spouse). The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, TAVR Publications Committee member, APOLLO Trial Screening Committee member, and IMPACT MR Steering Committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, Advisory Board member, and TRILUMINATE Trial Anatomic Eligibility and Publications Committee member for Abbott Structural Heart; has served as an Advisory Board member for Boston Scientific and JenaValve; has served as a consultant for NeoChord, Shockwave Medical, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Lerakis is a member of the Publication Imaging Subcommittee for the TRILUMINATE Pivotal Trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Individuals suffering from polyvascular atherosclerotic disease (PolyVD) face a higher likelihood of adverse cardiovascular events. Additionally, inflammation, assessed by high-sensitivity C-reactive protein (hsCRP), affects residual risk following percutaneous coronary intervention (PCI). We aimed to explore the interplay between PolyVD and hsCRP in terms of clinical outcomes after PCI., Methods: Patients undergoing PCI for chronic coronary disease at a tertiary center between January 2012 and February 2020 were included for the current analysis. PolyVD was defined by additional history of cerebrovascular and/or peripheral artery disease. HsCRP levels were defined as elevated when the measured baseline concentration was > 3 mg/L. The primary outcome of interest was major adverse cardiovascular events (MACE), a composite of all-cause mortality, spontaneous MI, or target vessel revascularization., Results: Overall, 10,359 participants were included in the current study, with 17.4% affected by PolyVD and 82.6% included in the non-PolyVD subgroup. Patients with PolyVD had higher hsCRP levels than those without. Among the PolyVD group, a larger proportion (33.6%) exhibited elevated hsCRP compared to the non-PolyVD group (24.7%). Patients with both PolyVD and elevated hsCRP levels had significantly higher adverse event rates than all other subgroups at 1-year follow-up. Furthermore, an independent association between elevated hsCRP and MACE was observed within the PolyVD population, while this was not the case for individuals without PolyVD., Conclusion: A residual risk of adverse outcomes after PCI linked to inflammation appears to be present among individuals with PolyVD. This could help define further target populations for anti-inflammatory treatment options., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

A substantial number of patients may experience systemic inflammatory response syndrome (SIRS) and related adverse events after transcatheter aortic valve implantation and endovascular aortic aneurysm repair. Although a clear etiology has not been established, endothelial disruption and tissue-ischemic response secondary to the foreign material may represent the trigger events. A latency period (0 to 48 hours) may occur between the initial injury and onset of symptoms mirroring an initial local response followed by a systemic response. Clinical presentation can be mild or severe depending on external triggers and characteristics of the patient. Diagnosis is challenging because it simulates an infection, but lack of response to antibiotics, negative cultures are supportive of SIRS. Increased in-hospital stay, readmissions, major cardiovascular events, and reduced durability of the device used are the main complications. Treatment includes non-steroidal anti-inflammatory drugs or corticosteroids. In conclusion, further studies are warranted to fully explore pathophysiologic mechanisms underpinning SIRS and the possibility of enhancing device material immune compatibility to reduce the inflammatory reaction of the host tissue., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Patients may prefer percutaneous coronary intervention (PCI) over coronary artery bypass graft (CABG) surgery, despite heart team recommendations. The outcomes in such patients have not been examined. We sought to examine the results of PCI in patients who were recommended for but declined CABG., Methods and Results: Consecutive patients with stable ischemic heart disease and unprotected left main or 3-vessel disease or Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score >22 who underwent PCI after heart team review between 2013 and 2020 were included. Patients were categorized into 3 groups according to heart team recommendations on the basis of appropriate use criteria: (1) PCI-recommended; (2) CABG-eligible but refused CABG (CABG-refusal); and (3) CABG-ineligible. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. The study included 3687 patients undergoing PCI (PCI-recommended, n=1718 [46.6%]), CABG-refusal (n=1595 [43.3%]), and CABG-ineligible (n=374 [10.1%]). Clinical and procedural risk increased across the 3 groups, with the highest comorbidity burden in CABG-ineligible patients. Composite events within 1 year after PCI occurred in 55 (4.1%), 91 (7.0%), and 41 (14.8%) of patients in the PCI-recommended, CABG-refusal, and CABG-ineligible groups, respectively. After multivariable adjustment, the risk of the primary composite outcome was significantly higher in the CABG-refusal (hazard ratio [HR], 1.67 [95% CI, 1.08-3.56]; P =0.02) and CABG-ineligible patients (HR, 3.26 [95% CI, 1.28-3.65]; P =0.004) groups compared with the reference PCI-recommended group, driven by increased death and stroke., Conclusions: Cardiovascular event rates after PCI were significantly higher in patients with multivessel disease who declined or were ineligible for CABG. Our findings provide real-world data to inform shared decision-making discussions.

Background: The number of octogenarians referred to percutaneous coronary interventions (PCI) is rising steadily. The prevalence and prognostic impact of complex PCI (CPCI) in this vulnerable population has not been fully evaluated., Methods: Patients ≥80 years old who underwent PCI between 2012 and 2019 at Mount Sinai Hospital were included. Patients were categorized based on PCI complexity, defined as the presence of at least one of the following criteria: use of atherectomy, total stent length ≥60 mm, ≥3 stents implanted, bifurcation treated with at least 2 stents, PCI involving ≥3 vessels, ≥3 lesions, left main, saphenous vein graft or chronic total occlusion. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), or target-vessel revascularization (TVR), within 1 year after PCI. Secondary outcomes included major bleeding., Results: Among 2657 octogenarians, 1387 (52%) underwent CPCI and were more likely to be men and to have cardiovascular risk factors or comorbidities. CPCI as compared with no-CPCI was associated with a higher 1-year risk of MACE (16.6% vs. 11.1%, adjusted HR 1.3, 95% CI 1.06-1.77, p value 0.017), due to an excess of MI and TVR, and major bleeding (10% vs. 5.8%, adjusted HR 1.64, 95% CI 1.20-2.55, p value 0.002)., Conclusions: Among octogenarians, CPCI was associated with a significantly higher 1-year risk of MACE, due to higher rates of MI and TVR but not of all-cause death, and of major bleeding. Strategies to reduce complications should be implemented in octogenarians undergoing CPCI., (© 2024 Wiley Periodicals LLC.)

Ventricular aneurysm represents a rare complication of transmural acute myocardial infarction, although other cardiac, congenital, or metabolic diseases may also predispose to such condition. Ventricular expansion includes all the cardiac layers, usually with a large segment involved. Adverse events include recurrent angina, reduced ventricular stroke volume with congestive heart failure, mitral regurgitation, thromboembolism, and ventricular arrhythmias. Multimodality imaging is paramount to provide comprehensive assessment, allowing for appropriate therapeutic decision-making. When indicated, surgical intervention remains the gold standard, although additional therapy (heart failure, anticoagulation, and advanced antiarrhythmic treatment) might be required. However, the STICH (Surgical Treatment for Ischemic Heart Failure) trial did not show any advantage from adding surgical ventricular reconstruction to coronary artery bypass surgery in terms of survival, rehospitalization or symptoms, compared with revascularization alone. Finally, implantable cardiac defibrillator may reduce the risk of fatal arrhythmias., Competing Interests: Funding Support and Author Disclosures Dr Lorusso is principal investigator of the Perceval Sutureless Implant versus Standard Aortic Valve Replacement (PERSIST-AVR) Study, sponsored by LivaNova; and is a consultant for Medtronic, LivaNova, Abiomed, and Eurosets with all honoraria paid to the University. 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. All rights reserved.)

Background: Diabetes mellitus (DM) is associated with a high rate of major adverse cardiac events (MACE) after de novo coronary artery percutaneous coronary intervention (PCI). Whether patients with DM undergoing PCI for in-stent restenosis (ISR) experience a similar heightened risk of MACE is not known. Hence, we sought to compare the clinical outcomes of patients with and without DM undergoing PCI for ISR., Methods: Patients undergoing first episode ISR PCI between January 2015 and December 2021 were included. The primary outcome of interest was MACE (all-cause death, myocardial infarction [MI], and target lesion revascularization [TVR]) at 1-year., Results: A total of 3156 patients (56.7% with DM) underwent PCI for ISR during the study period. Patients with DM were younger, more likely to be female, and had a higher prevalence of comorbidities. At 1-year follow-up, DM was associated with a higher rate of MACE (22.4% vs. 18.7%, unadjusted HR 2.03, 95%CI(1.27-3.25), p = 0.003). All-cause mortality and MI were significantly more frequent among people with DM at 1-year follow-up. The rate of TVR was similar in both groups (17.9% vs. 16.0%, unadjusted HR 1.14, 95%CI (0.94-1.37), p = 0.180). On adjusted analysis, there was no significant difference in the rate of MACE (AHR 1.07, 95%CI(0.90 - -1.29), p = 0.444), all-cause death (AHR 1.54, 95%CI(0.93-2.54), p = 0.095) or MI (AHR 1.10, 95%CI(0.74-1.63), p = 0.652)., Conclusion: ISR PCI in patients with DM was associated with a higher rate of MACE at 1-year follow-up. However, this increased risk was no longer significant after adjusting for baseline characteristics., Competing Interests: Declaration of competing interest A. Dr. Mehran has received institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, and Zoll; has received personal fees from the American College of Cardiology, Boston Scientific, the California Institute for Regenerative Medicine, Cine-Med Research, Janssen, WebMD, and the Society for Cardiovascular Angiography and Interventions; has received consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Philips; holds equity (<1%) in Applied Therapeutics, Elixir Medical, STEL, and CONTROLRAD (spouse); has served as a scientific advisory board member for the American Medical Association. B. All other authors have no conflicts of interest to declare., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Competing Interests: Declaration of competing interest Dr. Spirito reports a relation with Swiss National Science Foundation that includes funding grants. Dr. Mehran reports a relation with Abbott Vascular Inc that includes funding grants; a relation with AstraZeneca that includes funding grants; and a relation with the Society for Cardiovascular Angiography and Interventions that includes funding grants. The remaining authors have no competing interests to declare.

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.

Background: Coronary alignment is proposed as an alternative to commissural alignment for reducing coronary overlap during transcatheter aortic valve replacement (TAVR). However, largescale studies are lacking., Objectives: This study aimed to determine the incidence of coronary overlap with commissural vs coronary alignment using computed tomography (CT) simulation in patients undergoing TAVR evaluation., Methods: In 1,851 CT scans of native aortic stenosis patients undergoing TAVR evaluation (April 2018 to December 2022),virtual valves simulating commissural and coronary alignment were superimposed on axial aortic root images. Coronary overlap was assessed based on the angular gap between coronary artery origin and the nearest transcatheter heart valve commissure, categorized as severe (≤15°), moderate (15°-30°), mild (30°-45°), and no-overlap (45°-60°)., Results: The overall incidence of moderate/severe and severe overlap with either coronary artery remained rare with either coronary or commissural alignment (coronary 0.52% left, 0.52% right; commissural 0.30% left, 3.27% right). Comparing techniques, coronary alignment reduced moderate/severe overlap only for the right coronary artery (0.38% vs 2.97%; P <0.0001). For the left coronary artery, both techniques showed similar moderate/severe overlap, but commissural alignment had significantly higher no-overlap rates (91.1% vs 84.9%; P < 0.0001). Fluoroscopic angle during valve deployment was strongly correlated between commissural and coronary alignment (r = 0.80; P < 0.001)., Conclusions: Using CT simulation, the incidence of coronary overlap with transcatheter heart valve-commissure is rare with commissural alignment. Coronary alignment reduced right coronary overlap, whereas commissural alignment had higher rates of no left coronary overlap. Coronary alignment should be reserved only when commissural alignment results in severe coronary overlap., Competing Interests: Funding Support and Author Disclosures Dr Koshy is supported by a postdoctoral fellowship from the Heart Foundation of Australia. Dr Tang is a proctor for Medtronic; a consultant for Medtronic, Abbott Structural Heart, and NeoChord; advisory board member for Medtronic, Abbott Structural Heart, Boston Scientific, and JenaValve; and has received speaker honoraria from Siemens Healthineers. Dr Khera is a consultant for Abbott Structural Heart, Terumo, Eastend Medical, Medtronic, and W.L. Gore; is a proctor for Medtronic; and serves on the speaker board for Zoll Medical. 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: Redo-transcatheter aortic valve replacement (TAVR) can pin the index transcatheter heart valve leaflets open leading to sinus sequestration and restricting coronary access. The impact of initial implant depth and commissural alignment on redo-TAVR feasibility is unclear. We sought to determine the feasibility of redo-TAVR and coronary access after SAPIEN 3 (S3) TAVR stratified by implant depth and commissural alignment., Methods: Consecutive patients with native valve aortic stenosis were evaluated using multidetector computed tomography. S3 TAVR simulations were done at 3 implant depths, sizing per manufacturer recommendation and assuming nominal expansion in all cases. Redo-TAVR was deemed unfeasible based on valve-to-sinotubular junction distance and valve-to-sinus height <2 mm, while the neoskirt plane of the S3 transcatheter heart valve estimated coronary access feasibility., Results: Overall, 1900 patients (mean age, 80.2±8 years; STS-PROM [Society of Thoracic Surgeons Predicted Risk of Operative Mortality], 3.4%) were included. Redo-TAVR feasibility reduced significantly at shallower initial S3 implant depths (2.3% at 80:20 versus 27.5% at 100:0, P <0.001). Larger S3 sizes reduced redo-TAVR feasibility, but only in patients with a 100:0 implant ( P <0.001). Commissural alignment would render redo-TAVR feasible in all patients, assuming the utilization of leaflet modification techniques to reduce the neoskirt height. Coronary access following TAV-in-TAV was affected by both index S3 implant depth and size., Conclusions: This study highlights the critical impact of implant depth, commissural alignment, and transcatheter heart valve size in predicting redo-TAVR feasibility. These findings highlight the necessity for individualized preprocedural planning, considering both immediate results and long-term prospects for reintervention as TAVR is increasingly utilized in younger patients with aortic stenosis., Competing Interests: Dr Koshy is supported by a postdoctoral scholarship from the Heart Foundation of Australia. Dr Khera is a speaker for Medtronic and Zoll Medical; a proctor for Medtronic; and a consultant for Terumo, Medtronic, Abbott, and Boston Scientific. Dr Tang is a physician proctor for Medtronic; a consultant for Medtronic, Abbott Structural Heart, and NeoChord; a physician advisory board member for Abbott Structural Heart, Boston Scientific, and JenaValve; and receives speaker’s honoraria from Siemens Healthineers. The other authors report no conflicts.

Background: The risks of prefrail and frail women undergoing transcatheter aortic valve replacement (TAVR) have not been fully examined. The aim of the analysis was to assess the prognostic impact of prefrailty and frailty in women undergoing TAVR., Methods: Women at intermediate or high surgical risk with severe aortic stenosis undergoing TAVR from the prospective multicentre WIN-TAVI (Women's International Transcatheter Aortic Valve Implantation) registry were stratified based on the number of Fried frailty criteria (weight loss, exhaustion, low physical activity, slow gait, weakness) met: nonfrail (no criteria), prefrail (1 or 2 criteria), or frail (3 or more criteria). The primary outcome at 1 year was the Valve Academic Research Consortium 2 (VARC-2) efficacy end point, a composite of mortality, stroke, myocardial infarction, hospitalisation for valve-related symptoms or heart failure, and valve-related dysfunction; secondary outcomes included the composite of VARC-2 life-threatening or major bleeding., Results: Out of 1019 women, 297 (29.1%) met at least 1 frailty criterion: 264 (25.9%) had prefrailty and 33 (3.2%) frailty. The 1-year risk of the primary outcome was significantly higher in prefrail and frail (20.2%) than in nonfrail (14.9%) women (adjusted hazard ratio [aHR] 1.51, 95% confidence interval [CI] 1.07-2.12). The risk of VARC-2 life-threatening or major bleeding was higher in prefrail or frail (19.9%) than in nonfrail (10.0%) women (aHR 2.06, 95% CI 1.42-2.97). These risks were consistently increased in the prefrail and frail groups assessed separately., Conclusions: In women undergoing TAVR, the presence of prefrailty or frailty conferred an increased risk of the VARC-2 efficacy end point and of VARC-2 life-threatening or major bleeding., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Contrast-induced encephalopathy (CIE) is an idiopathic reaction following iodine-contrast dye administration in patients undergoing angiographic procedures. While it has been well-documented following coronary and carotid interventions, literature on CIE following transcatheter aortic valve replacement is limited. We report the multidisciplinary management of 3 patients with CIE following transcatheter aortic valve replacement., (© 2024 The Author(s).)

Background: Transcatheter edge-to-edge repair (TEER) improved outcomes in patients with heart failure (HF) and severe secondary mitral regurgitation (SMR) compared with guideline-directed medical therapy (GDMT) alone regardless of the severity of baseline left ventricular ejection fraction (LVEF). The study aimed to evaluate the effect of early changes in LVEF after TEER and GDMT alone in patients with HF and severe SMR., Methods: Within the COAPT trial, we evaluated outcomes according to changes in LVEF from baseline to 30 days. The primary outcome was all-cause death or HF hospitalization (HFH) between 30 days and 2 years., Results: Among 432 patients with paired echocardiographic data, 182 (42.1%) had increased LVEF (LVEF change 6.0% ± 4.9%) and 250 (57.9%) had a decrease or no change in LVEF (LVEF change -6.6% ± 5.6%) from baseline to 30 days. LVEF at 30 days increased more frequently with GDMT alone compared with TEER plus GDMT (51.4% vs 33.0%; P = .0001). Between 30 days and 2 years, there were no significant differences in death or HFH in the increase LVEF and the decrease LVEF groups (58.8% vs 51.4%; multivariable-adjusted HR, 0.97; 95% CI, 0.87-1.08; P = .59). TEER plus GDMT reduced the 30-day to 2-year rate of death or HFH compared with GDMT alone consistently in patients with increase LVEF and decrease LVEF (P int = 0.75)., Conclusions: Among patients with HF and severe SMR, early improvements in LVEF were more frequent with GDMT alone compared with TEER plus GDMT but were not associated with subsequent outcomes at 2 years. TEER reduced death or HFH during 2-year follow-up irrespective of early LVEF changes., (© 2024 The Author(s).)

Background: Markers of systemic inflammation, such as high-sensitivity C-reactive protein (hsCRP), have been associated with the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention (PCI). Whether this risk varies according to the presence of high bleeding risk (HBR) conditions is unclear., Objectives: The aim of this study was to evaluate the impact of systemic inflammation, as measured by hsCRP levels and cardiovascular outcomes in patients stratified by HBR status following PCI., Methods: Consecutive patients undergoing PCI between 2012 and 2019 with baseline hsCRP levels were included. High hsCRP was defined as >3 mg/L, and HBR was defined per the Academic Research Consortium HBR criteria. The primary outcome was MACCE, including all-cause death, myocardial infarction, or stroke at 1 year. All bleeding was assessed as a secondary outcome., Results: A total of 15,150 patients were included, and 40.4% (n = 6,125) qualified as HBR. The adjusted risk for MACCE was consistently higher in patients with high hsCRP in both HBR (adjusted HR [aHR]: 1.49; 95% CI: 1.18-1.87) and non-HBR (aHR: 1.87; 95% CI: 1.31-2.66) subgroups, with no interaction between HBR status and hsCRP level (P interaction  = 0.26). Conversely, although bleeding risk was higher in the HBR cohort, hsCRP did not predict the occurrence of bleeding in either the HBR (aHR: 1.04; 95% CI: 0.82-1.31) or the non-HBR (aHR: 0.99; 95% CI: 0.71-1.39) subgroup (P interaction  = 0.539)., Conclusions: Elevated hsCRP at the time of PCI is associated with a higher risk for ischemic but not bleeding events, irrespective of HBR status., Competing Interests: Funding Support and Author Disclosures Dr Dangas has received institutional research grants from Abbott Laboratories, AstraZeneca, Bayer, Boston Scientific, Medtronic, and Daiichi Sankyo; has received consultant fees from Biosensors International and Boston Scientific; and has received speaker honoraria from Chiesi. Dr Sharma has received consulting fees or honoraria from Abbott, Boston Scientific, Abiomed, and Cardiovascular Systems. Dr Mehran has received institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Cardiawave, CellAegis Devices, the European Cardiovascular Research Center, Chiesi, Concept Medical, CSL Behring, Data Sciences International, Insel Gruppe, Medtronic, OrbusNeich, Philips, Transverse Medical, and Zoll; has received personal fees from the American College of Cardiology, Boston Scientific, the California Institute for Regenerative Medicine, CineMed, Janssen, WebMD, and the Society for Cardiovascular Angiography and Interventions; has received consulting fees paid to the institution from Abbott, Abiomed, AM-Pharma, Alleviant Medical, Bayer, Cardiawave, CeloNova BioSciences, Chiesi, Concept Medical, CSL Behring, Data Sciences International, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Philips; holds equity (<1%) in Applied Therapeutics, Elixir Medical, STEL, and ControlRad (spouse); is a scientific advisory board member for the American Medical Association and Biosensors International (spouse); and is a faculty member at the Cardiovascular Research Foundation (no fee). 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: Peripheral artery disease (PAD) is associated with worse outcomes after percutaneous coronary intervention (PCI). The aim of this study was to assess the prognostic impact of PAD according to high bleeding risk (HBR) status., Methods: Consecutive patients undergoing PCI with drug-eluting stent implantation at a tertiary-care center (Mount Sinai Hospital) between 2012 and 2019 were stratified according to HBR and PAD status. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and stroke 1 year after PCI. Secondary outcomes included major bleeding., Results: Out of 16,750 patients, 43% were HBR and 57% were no-HBR. Within the two groups, PAD patients were 14% and 6%, respectively, and were more likely to have comorbidities and to undergo complex PCI than no-PAD patients. Within the HBR group, PAD was associated with an increased risk of MACE (11.4% vs. 7.3%, hazard ratio [HR]: 1.59, 95% confidence interval [CI]: 1.27-1.99, p < 0.001) and a numerical nonsignificant increase of major bleeding (8.5% vs. 6.9%, HR: 1.25, 95% CI: 0.98-1.59, p = 0.066) as compared with no-PAD. Among no-HBR patients, rates of MACE and major bleeding were numerically but not significantly higher in the PAD group. After multivariable adjustment, PAD was no longer a predictor of adverse outcomes, irrespective of HBR status., Conclusions: At 1-year after PCI, PAD was associated with increased 1-year risks of MACE in HBR patients. After adjustment for cardiovascular risk factors and comorbidities, the effect of PAD on adverse events was largely attenuated., (© 2024 Wiley Periodicals LLC.)

Background: Among patients undergoing percutaneous coronary intervention (PCI), in-stent restenosis (ISR) is related with a worse prognosis, while higher body mass index (BMI) values are associated with better outcomes. It is unclear whether the prognostic impact of ISR varies in function of BMI., Methods: Patients undergoing PCI at a large center from 2012 to 2019 not presenting with an acute myocardial infarction (MI) were included. Subjects with BMI < 18.5 kg/m 2 or treated with bare metal stents were excluded. Patients were stratified according to type of lesion treated (ISR vs. no-ISR) and into four BMI categories: normal weight (BMI 18.5-25 kg/m 2 ), overweight (25.0-29.9 kg/m 2 ), class I obesity (30.0-34.9 kg/m 2 ), class II-III obesity (≥35.0 kg/m 2 ). The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, MI, and target vessel revascularization (TVR) at 1 year., Results: Out of 16,234 patients, 3694 (23%) underwent PCI for ISR. ISR as compared to no-ISR was associated with a consistent increased risk of MACE within the normal weight (18.8% vs. 7.8%, adj. hazard ratio (HR): 1.99, 95% confidence interval [CI]: 1.51-2.64), overweight (19.1% vs. 6.4%, adj. HR: 2.35, 95% CI: 1.91-2.88), class I obesity (18.3% vs. 6.8%, adj. HR: 1.95, 95% CI: 1.47-2.57), and class II-III obesity (16.4% vs. 7.4%, adj. HR: 1.61, 95% CI: 1.09-2.37) groups (interaction p-value: 0.192). The ISR-related risks were mostly driven by an excess of TVR., Conclusions: At 1 year, ISR was associated with an increased risk of MACE irrespective of BMI, mostly due to an excess of TVR after ISR., (© 2024 Wiley Periodicals LLC.)

Aims: In patients with severe aortic stenosis (AS), low-flow low-gradient (LG) is a known predictor of worse outcomes. However, very LG may represent a distinct population with further cardiac dysfunction. It is unknown whether this population benefits from transcatheter aortic valve replacement (TAVR). We aimed to describe the patient characteristics and clinical outcomes of low-flow very LG severe AS., Methods and Results: This single-centre study included all patients with low-flow severe AS between 2019 and 2021. Patients were divided into groups with very LG [mean pressure gradient (MPG) ≤ 20 mmHg], LG (20 < MPG < 40 mmHg), and high-gradient (HG) (MPG ≥ 40 mmHg). Composite endpoint of all-cause mortality and heart failure rehospitalization was compared. A total of 662 patients [very LG 130 (20%); LG 339 (51%); HG 193 (29%)] were included. Median follow-up was 12 months. Very LG cohort had a higher prevalence of comorbid conditions with lower left ventricular ejection fraction (45% vs. 57% vs. 60%; P < 0.001). There was a graded increase in the risk of composite endpoint in the lower MPG strata (P < 0.001). Among those who underwent TAVR, very LG was an independent predictor of the composite endpoint (adjusted HR 2.42 [1.29-4.55]). While LG and HG cohorts had decreased risk of composite endpoint after TAVR compared with conservative management, very LG was not associated with risk reduction (adjusted HR 0.69 [0.35-1.34])., Conclusion: Low-flow very LG severe AS represents a distinct population with significant comorbidities and worse outcomes. Further studies are needed to evaluate the short- and long-term benefits of TAVR in this population., Competing Interests: Conflict of interest: S.K.S.: speaker honoraria from Abbott, Boston Scientific, and Cardiovascular Systems, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

In the past two decades, transcatheter aortic valve replacement (TAVR) has transformed the management of aortic stenosis and has become the standard of care regardless of surgical risk levels. Advances in transcatheter valve design across newer generations, improved imaging, greater operator expertise, and technical enhancements have collectively contributed to increased safety and a decline in procedural complications over this timeframe. The application of TAVR has progressively expanded to include younger patients with lower risks, who have longer life expectancies. This article offers an up-to-date review of the latest innovations in transcatheter delivery systems, devices, and its possible future indications.

Aim: To assess the value of the thrombotic risk criteria proposed in the 2023 guidelines of the European Society of Cardiology (ESC) for the management of acute coronary syndrome (ACS) to predict the ischaemic risk after percutaneous coronary intervention (PCI)., Methods and Results: Consecutive patients with acute or chronic coronary syndrome undergoing PCI at a large tertiary-care center from 2014 to 2019 were included. Patients were stratified into low, moderate, or high thrombotic risk based on the ESC criteria. The primary endpoint was major adverse cardiovascular events (MACEs) at 1 year, a composite of all-cause death, myocardial infarction (MI), and stroke. Secondary endpoints included major bleeding. Among 11 787 patients, 2641 (22.4%) were at low-risk, 5286 (44.8%) at moderate risk, and 3860 (32.7%) at high-risk. There was an incremental risk of MACE at 1 year in patients at moderate (hazard ratios (HR) 2.53, 95% confidence interval (CI) 1.78-3.58) and high-risk (HR 3.39, 95% CI 2.39-4.80) as compared to those at low-risk, due to higher rates of all-cause death and MI. Major bleeding rates were increased in high-risk patients (HR 1.59, 95% CI 1.25-2.02), but similar between the moderate and low-risk group. The Harrell's C-index for MACE was 0.60., Conclusion: The thrombotic risk criteria of the 2023 ESC guidelines for ACS enable to stratify patients undergoing PCI in categories with an incremental 1 year risk of MACE; however, their overall predictive ability for MACE is modest. Future studies should confirm the value of these criteria to identify patients benefiting from an extended treatment with a second antithrombotic agent., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Functional coronary angiography (FCA) is a novel modality for assessing the physiology of coronary lesions, going beyond anatomical visualization by traditional coronary angiography. FCA incorporates indices like fractional flow reserve (FFR) and instantaneous wave-free ratio (IFR), which utilize pressure measurements across coronary stenoses to evaluate hemodynamic impacts and to guide revascularization strategies. In this review, we present traditional and evolving modalities and uses of FCA. We will also evaluate the existing evidence and discuss the applicability of FCA in various clinical scenarios. Finally, we provide insight into emerging evidence, current challenges, and future directions in FCA.

Background: Percutaneous coronary intervention (PCI) of calcified lesions remains challenging for interventionalists., Aims: We aimed to investigate whether combining rotational atherectomy (RA) with cutting balloon angioplasty (RA+CBA) results in more optimal stent expansion compared with RA followed by non-compliant balloon angioplasty (RA+NCBA)., Methods: ROTA-CUT is a prospective, multicentre, randomised trial of 60 patients with coronary artery disease undergoing PCI of moderately or severely calcified lesions with drug-eluting stent implantation. Patients were randomised 1:1 to either RA+CBA or RA+NCBA. The primary endpoint was the minimum stent area on intravascular ultrasound (IVUS). Secondary endpoints included minimum lumen area and stent expansion assessed by IVUS and acute lumen gain, final residual diameter stenosis and minimum lumen diameter assessed by angiography. Clinical endpoints were obtained at 30 days., Results: The mean age was 71.1±9.4 years, and 22% were women. The procedural details of RA were similar between groups, as were procedure duration and contrast use. Minimum stent area was similar with RA+CBA versus RA+NCBA (6.7±1.7 mm 2 vs 6.9±1.8 mm 2 ; p=0.685). Furthermore, there were no significant differences regarding the other IVUS and angiographic endpoints. Procedural complications were rare, and 30-day clinical events included 2 myocardial infarctions and 1 target vessel revascularisation in the RA+CBA group and 1 myocardial infarction in the RA+NCBA group., Conclusions: Combining RA with CBA resulted in a similar minimum stent area compared with RA followed by NCBA in patients undergoing PCI of moderately or severely calcified lesions. RA followed by CBA was safe with rare procedural complications and few clinical adverse events at 30 days.

Prognostic implications of pulmonary hypertension (PH) in low-flow low-gradient (LG) aortic stenosis (AS) after transcatheter aortic valve replacement (TAVR) remains unexplored. We aimed to investigate the impact of baseline and changes in PH after TAVR. In this single-center retrospective study, we included patients who underwent TAVR for low-flow LG AS. Patients were categorized into 2 groups: baseline pulmonary artery systolic pressure (PASP) <46 mm Hg (no-to-mild PH) and PASP ≥46 mm Hg (moderate-to-severe PH). On the basis of changes in PASP after TAVR, patients were stratified into increased (ΔPASP ≥ + 5 mm Hg), no change (-4 to +4 mm Hg), and decreased (≤ -5 mm Hg) groups. Primary end point was a composite of all-cause mortality and heart failure rehospitalization. In total, 210 patients were included, 148 in the no-to-mild PH group and 62 in the moderate-to-severe PH group. Median follow-up was 13.2 months. The moderate-to-severe PH group was at an increased risk of composite end point (adjusted hazard ratio [HR] 3.5, 95% confidence interval [CI] 1.8 to 6.9), all-cause mortality (HR 2.4, 95% CI 1.1 to 5.6), and heart failure rehospitalization (HR 8.3, 95% CI 2.9 to 23.7). There were no differences in clinical outcomes among those with increased (32%), no change (28%), and decreased (39%) PASP after TAVR. In conclusion, moderate-to-severe PH at baseline is an independent predictor of worse clinical outcomes in patients with low-flow LG AS who undergo TAVR, and this cohort of patients do not seem to derive the benefits of postoperative reduction of PASP., Competing Interests: Declaration of Competing Interest Dr. Sharma receives speaker honoraria from Abbott, Boston Scientific, and Cardiovascular Systems Inc. Dr. Khera serves as a proctor and consultant for Medtronic, a consultant for Abbott Structural Heart, Eastend Medical, and W. L. Gore & Associates, and is on the speakers’ board for Zoll Medical. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Patients who undergo percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) are at a high risk for both periprocedural and post-procedural adverse events. Whether gender-differences in outcomes exist after PCI of CTO remain unclear. Therefore, we sought to investigate gender-based differences in outcomes after CTO-PCI. All patients who underwent elective CTO intervention from January 2012 to December 2017 at The Mount Sinai Hospital (New York, New York) were included. The primary end point of interest was major adverse cardiac events defined as the composite of death, myocardial infarction, and target vessel revascularization at 1 year of follow-up. A total 1,897 patients were included, of which 368 were women (19.4%). Mean follow-up time was 174 days. Women were older (66.8 ± 11.3 years vs 62.6 ± 10.9 years) and had a higher prevalence of co-morbidities including diabetes and chronic kidney disease. There were no significant differences in the rate of successful CTO-PCI between groups (73.5% vs 73.2%, p = 0.91). Women had higher rates of procedure-related complications including increased risk of post-procedural bleeding (4.1% vs 1.8%, p = 0.009) and acute vessel closure (1.36% vs 0.2%, p = 0.009). In multivariable-adjusted analysis, female gender was associated with higher risk of major adverse cardiac event and target vessel revascularization at 1 year. In conclusion, in this large single-center study, women who underwent percutaneous CTO revascularization experienced higher rates of periprocedural complications and worse clinical outcomes at 1 year compared with men. Further research is needed to address disparities in gender-specific outcomes of CTO-PCI., Competing Interests: Declaration of Competing Interest Dr. Kini reports as industry-sponsored lectures: miscellaneous teaching and lectures at academic institutions. Roxana Mehran: consulting: Dr. Kieffer reports as Equity: Elixir Medical Corporation, STEL, ControlRad; industry-sponsored lectures: Asan University South Korea, Brazilian Cardiology Society, COLOMBIA webinar, China Cardiology Conference, Europa Group, Gaffney Events, India Webinar, India Webinar Mumbai, Samin Sharma Foundation, Society for Cardiovascular Angiography and Interventions, St. Francis Hospital, Taiwan Cardiology Conference, Tarsus, University of Florence, University of Purchase, WebMD, webinar APSCJCS; Scientific Advisory Board: American College of Cardiology. Dr. Sharma reports as equity: Eternal Heart Care Centre and Research Institute Private Limited; Industry Sponsored Lectures: Abbott Laboratories, Boston Scientific Corporation, Cardiovascular Systems, Inc., miscellaneous teaching and lectures at academic institutions. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Lack of standardization in posttranscatheter aortic valve replacement (TAVR) conduction disturbance (CD) identification and treatment may affect permanent pacemaker implantation (PPI) rates and clinical outcomes. The safety and efficacy of a standardized TAVR CD algorithm has not been analyzed. This study analyzes the Optimize PRO post-TAVR CD management algorithm with Evolut PRO/PRO + valves., Methods: Optimize PRO is a prospective, postmarket study implementing 2 strategies to reduce pacemaker rates: TAVR with cusp overlap technique and a post-TAVR CD algorithm. The 2-hour postprocedural electrocardiogram (ECG) stratified patients to early discharge in the absence of new ECG changes or to CD algorithms for (1) ECG changes with preexisting right or left bundle branch block (LBBB), interventricular conduction delay or first-degree atrioventricular block, (2) new LBBB, or (3) high-degree atrioventricular block (HAVB)., Results: The interim analysis of the CD cohort consisted of 125/400 TAVR recipients. In the CD cohort, the 30-day new PPI rate was higher (28.1% vs 1.5%; P <.001), and 60 (48%) patients were discharged with a 30-day continuous ECG monitor. At 30 days, 90% of patients discharged with a monitor did not require PPI. Clinical outcomes, including mortality, stroke, bleeding, and reintervention, were similar in patients with and without CDs. No patient experienced sudden cardiac death., Conclusions: Effective management of CDs using a standard algorithm following Evolut TAVR provides similar 30-day safety outcomes to patients without CDs who undergo routine next day discharge. The CD algorithm may provide an effective strategy to recognize arrhythmias early, improve PPI utilization, and facilitate safe monitoring of patients after discharge., (© 2023 The Author(s).)