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OBJECTIVE: The purpose of this meta-analysis was to compare outcomes for AngioJet thrombectomy versus percutaneous coronary intervention (PCI) without thrombectomy in acute myocardial infarction (AMI) patients. BACKGROUND: PCI is the preferred treatment for revascularizing the infarct-related artery in patients with AMI. There is controversy about the benefits of thrombectomy as an adjunct to PCI. METHODS: AMI studies published between January 1, 1999, and March 1, 2007, were used to compare AngioJet thrombectomy plus PCI to PCI alone. Bayesian meta-analytic estimates were used to estimate the odds ratios (95% CI) for short-term mortality, major adverse cardiac events (MACE), and final TIMI 3 flow. RESULTS: The AngioJet data included 11 studies and 1,018 patients. The PCI data included 81 studies and 24,076 patients. The AngioJet group included more patients with large thrombus burden, rescue PCI after failed thrombolytic therapy, and longer symptom duration compared to the PCI group. Despite the higher risk profile of AngioJet patients, the groups had similar odds of short-term mortality, 0.98 (0.53, 1.50), MACE, 1.25 (0.54, 2.40), and final TIMI 3 flow, 1.12 (0.70, 2.27). CONCLUSION: AngioJet thrombectomy results in clinical and angiographic outcomes that are similar to PCI in lower risk AMI patients. These observations suggest that AngioJet thrombectomy may reduce the additional risk associated with visible thrombus in the infarct-related lesion. [ABSTRACT FROM AUTHOR]

In this paper, we identify the key parameters to consider in a decision model on internationalization of operations. In order to propose these parameters, the GLOBOPE framework was adopted as the basis of this work. This framework contemplates the three commonest challenges of global operations configuration for industrial manufacturing companies in an internationalization process, which are: new facility implementation (NFI); global suppliers’ network development (GSND); multisite production network configuration. A set of suitable parameters is herein provided for NFI and GSND in the analysis stage from strategic, tactical and operational decision levels. These parameters could be used in the future as a basis for the development of quantitative tools for decision making on the internationalization of operations.

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763)., (Copyright © 2022 The Society of Thoracic Surgeons and The American College of Cardiology Foundation. Published by Elsevier Inc. Published by Elsevier Inc. All rights reserved.)

Data for nearly all patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States is captured in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported. A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites and for TMVR from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the U.S. Food and Drug Administration in 2017, and the 2019 30-day mortality rate was 3.9%. Overall improvements in outcomes over the last 6 years are apparent. (STS/ACC TVT Registry Mitral Module; NCT02245763)., Competing Interests: Funding Support and Author Disclosures Dr Mack has served as uncompensated co–principal investigator for the Partner 3 Trial by Edwards Lifesciences, study chair for the Apollo Trial by Medtronic, and co–principal investigator for the Coapt Trial by Abbott, receiving only travel expenses for trial-related meetings. Dr Carroll has been a local investigator for Abbott (COAPT, TRILUMINATE, and EXPAND clinical trials), Edwards Lifesciences (PARTNER 2 and CLASP clinical trials), and Medtronic (Low Risk TAVR clinical trial; has been the chair of the data and safety monitoring board for Abbott Tendyne clinical trial; and has been a steering committee member for the Abbott RESPECT clinical trial. Dr Thourani has received consultancy and research grants from Abbott and Edwards Lifesciences. Dr Vemulapalli has received grants/contracts from Abbott, Boston Scientific, American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health, National Evaluation System for health Technology Coordinating Center (FDA); and has received consulting fees/served on the advisory board/Speakers Bureau for Boston Scientific, Janssen, HeartFlow, and American College of Physicians. Dr Deeb has been an executive committee and investigator for all the Medtronic TAVR Trials; has served on the surgical Advisory Committee for Medtronic; and has served on the data management committee for the Medtronic EV-ICD Trial (no personal reimbursement). Dr Batchelor has served as a consultant for V-Wave, Medtronic, Abbott, Boston Scientific, and Idorsia; and has received research support from Abbott and Boston Scientific. Dr Herrmann has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; has received consultant fees from Edwards Lifesciences and Medtronic; and has equity in Microinterventional Devices. Dr Cohen has received research grant support and consulting income from Abbott, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Hanzel has served as a local investigator for Abbott (COAPT and Summit clinical trials), Boston Scientific (REPRISE III and REPRISE IV clinical trials), and Edwards Lifesciences (PARTNER 2 and PARNTER 3 clinical trials). Dr Gleason serves on the medical advisory board for Abbott. 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; has received institutional funding, including fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting; has received 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 Desai has received speaking fees from Medtronic, Gore, and Terumo; and has received research grants from Gore and Medtronic. Dr Brindis serves as Senior Medical Officer, External Affairs, ACC National Cardiovascular Data Registry. Dr Masoudi has a contract with the ACC for his role as Chief Scientific Advisor, National Cardiovascular Data Registry. Dr Bavaria has served as a site principal investigator on clinical trials for Edwards Lifesciences, Medtronic, W.L. Gore, and Abbott; has served as a consultant for Edwards Lifesciences, W.L. Gore, and Abbott; has served on the Speakers Bureau for Medtronic; and has served as data and safety monitoring board chair for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 by The American College of Cardiology Foundation and The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background Concerns about discordance between echocardiographic and invasive mean gradients after transcatheter aortic valve replacement (TAVR) with balloon-expandable valves (BEVs) versus self-expanding valves (SEVs) exist. Methods and Results In a multicenter study, direct-invasive and echocardiography-derived transvalvular mean gradients obtained before and after TAVR were compared as well as post-TAVR and discharge echocardiographic mean gradients in BEVs versus SEVs in 808 patients. Pre-TAVR, there was good correlation ( R =0.614; P <0.0001) between direct-invasive and echocardiography-derived mean gradients and weak correlation ( R =0.138; P <0.0001) post-TAVR. Compared with post-TAVR echocardiographic mean gradients, both valves exhibit lower invasive and higher discharge echocardiographic mean gradients. Despite similar invasive mean gradients, a small BEV exhibits higher post-TAVR and discharge echocardiographic mean gradients than a large BEV, whereas small and large SEVs exhibit similar post-TAVR and discharge mean gradients. An ejection fraction <50% ( P =0.028) and higher Society of Thoracic Surgeons predicted risk of mortality score ( P =0.007), but not invasive or echocardiographic mean gradient ≥10 mm Hg ( P =0.378 and P =0.341, respectively), nor discharge echocardiographic mean gradient ≥20 mm Hg ( P =0.393), were associated with increased 2-year mortality. Conclusions Invasively measured and echocardiography-derived transvalvular mean gradients correlate well in aortic stenosis but weakly post-TAVR. Post-TAVR, echocardiography overestimates transvalvular mean gradients compared with invasive measurements, and poor correlation suggests these modalities cannot be used interchangeably. Moreover, echocardiographic mean gradients are higher on discharge than post-TAVR in all valves. Despite similar invasive mean gradients, a small BEV exhibits higher post-TAVR and discharge echocardiographic mean gradients than a large BEV, whereas small and large SEVs exhibit similar post-TAVR and discharge mean gradients. Immediately post-TAVR, elevated echocardiographic-derived mean gradients should be assessed with caution and compared with direct-invasive mean gradients. A low ejection fraction and higher Society of Thoracic Surgeons score, but not elevated mean gradients, are associated with increased 2-year mortality.

Objectives: To compare echocardiographic and invasive mean gradients obtained concomitantly in degenerated bioprosthetic surgical aortic valves (SAVRs)., Methods: In a multicenter study, we compared concomitant echocardiographic and invasive mean gradients of SAVR, obtained before valve-in-valve transcatheter aortic valve replacement in all patients, patients with primary stenosis (AS), primary aortic regurgitation (AR), and mixed aortic valve disease (MAVD), and in small versus large valves (≤ or >23 mm). Dimensionless index (DI) was calculated in all groups., Results: In total, 74 patients were included and data presented as median (interquartile range). Echocardiography-catheterization mean gradient discordance was observed in all patients (invasive = 22 mm Hg [11-34] vs echocardiographic = 32 mm Hg [21-42], P  = .013), small valves (invasive = 15 mm Hg [8-34] vs echocardiographic = 28 mm Hg [21-41], P  = .013), and large valves (invasive = 20 mm Hg [8.5-27.13] vs echocardiographic = 32 mm Hg [25.5 - 41.5], P  < .0001), with a bias of 8 ± 15 mm Hg and wide limits of agreement (-22 to 39 mm Hg) on Bland-Altman plots, indicating these modalities may not be interchangeable. Discordance occurred in AR (invasive = 3 mm Hg [1-6] vs echocardiographic = 12 mm Hg [7-22], P  = .017) and in MAVD (invasive = 19 mm Hg [12-29] vs echocardiographic = 31 mm Hg [23-39], P  < .0001) but not in AS (invasive = 35 mm Hg [24-45] vs echocardiographic = 41 mm Hg [30-50], P  = .45). A lower DI (0.21 [0.14-0.25]) occurred in AS compared with MAVD (0.31 [0.19-0.39]) and AR (0.55 [0.51-0.69]), P  < .0001., Conclusions: Discordance between echocardiography and invasive mean gradients exists in degenerated SAVR, regardless of valve size, but depends on mechanism of failure and DI helps stratify these patients. With a discrepancy between echocardiographic mean gradients AND the patient's symptoms OR the valve leaflet structure and/or mobility on imaging, especially before redo-SAVR or valve-in-valve transcatheter aortic valve replacement, invasive gradients may adjudicate the true valvular hemodynamics., (© 2021 The Authors.)

Background: Cigarette smoking, hypertension, dyslipidemia, diabetes, and obesity are conventional risk factors (RFs) for coronary artery disease (CAD). Population trends for these RFs have varied in recent decades. Consequently, the risk factor profile for patients presenting with a new diagnosis of CAD in contemporary practice remains unknown., Objectives: To examine the prevalence of RFs and their temporal trends among patients without a history of myocardial infarction or revascularization who underwent their first percutaneous coronary intervention (PCI)., Methods: We examined the prevalence and temporal trends of RFs among patients without a history of prior myocardial infarction, PCI, or coronary artery bypass graft surgery who underwent PCI at 47 non-federal hospitals in Michigan between 1/1/2010 and 3/31/2018., Results: Of 69,571 men and 38,930 women in the study cohort, 95.5% of patients had 1 or more RFs and nearly half (55.2% of women and 48.7% of men) had ≥3 RFs. The gap in the mean age at the time of presentation between men and women narrowed as the number of RFs increased with a gap of 6 years among those with 2 RFs to <1 year among those with 5 RFs. Compared with patients without a current/recent history of smoking, those with a current/recent history of smoking presented a decade earlier (age 56.8 versus 66.9 years; p <0.0001). Compared with patients without obesity, patients with obesity presented 4.0 years earlier (age 61.4 years versus 65.4 years; p <0.0001)., Conclusions: Modifiable RFs are widely prevalent among patients undergoing their first PCI. Smoking and obesity are associated with an earlier age of presentation. Population-level interventions aimed at preventing obesity and smoking could significantly delay the onset of CAD and the need for PCI., Competing Interests: Dr. Devraj Sukul and Mr. Milan Seth receive salary support from the Blue Cross Blue Shield of Michigan (BCBSM) for their work in BMC2. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The other authors do not have any direct conflicts or competing interest that could affect the study or its data presentation. The opinions, beliefs and viewpoints expressed by the authors do not necessarily reflect those of BCBSM or any of its employees.

Objectives: This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure., Background: Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking., Methods: The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events., Results: Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection., Conclusions: BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction., Competing Interests: Funding Support and Author Disclosures This work was supported by National Heart, Lung, and Blood Institute grant Z01-HL006061. Drs. Khan, Rogers, and Lederman are co-inventors on patents, assigned to National Institutes of Health, on catheter devices to lacerate valve leaflets. Dr. Khan has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Babaliaros has served as a consultant for Edwards Lifesciences, Abbott Vascular, and Transmural Systems; and his employer has research contracts for clinical investigation of transcatheter aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific. Dr. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and owns equity in Transmural Systems. Dr. Depta has served as a consultant and on the advisory board for Edwards Lifesciences, Boston Scientific, and W.L. Gore and Associates. Dr. McCabe has received honoraria from and served as a consultant for Medtronic and Edwards Lifesciences. Dr. Muhammad has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott. Dr. Mahoney has served as a consultant and proctor for Edwards Lifesciences and Medtronic. Dr. Shah has served as a proctor Edwards Lifesciences; and has received educational grants from Edwards Lifesciences, Abbott, and Medtronic. Dr. Chhatriwalla has served on the Speakers Bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic; has served as a consultant for Boston Scientific and Silk Road Medical; has received research grant support from Boston Scientific; and has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Leonardi has served as a proctor for Edwards Lifesciences. Dr. Khalil has served as a proctor for Medtronic and Edwards Lifesciences. Dr. Tang has served as a physician proctor for Medtronic; and has served as a consultant for Medtronic, Abbott Structural Heart, and W.L. Gore and Associates. Dr. Herrmann has received institutional research funding from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting and speaking honoraria from Edwards Lifesciences and Medtronic. Dr. Fail has served as a proctor for Medtronic. Dr. Pop has served as consultant for Edwards Lifesciences. Dr. Lederman has served as the principal investigator on a Cooperative Research and Development Agreement between the National Institutes of Health and Edwards Lifesciences on transcatheter modification of the mitral valve. Dr. Waksman has served as a consultant for Medtronic and Abbott Vascular; and has received grant support from Abbott Vascular. Dr. Rogers has served as a consultant or proctor for Edwards Lifesciences and Medtronic; and owns equity in Transmural Systems. 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. All rights reserved.)

The STS-ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR's evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528)., (Copyright © 2021 The Society of Thoracic Surgeons and the American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The STS-ACC TVT Registry (Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry) from 2011 to 2019 has collected data on 276,316 patients undergoing transcatheter aortic valve replacement (TAVR) at sites in all U.S. states. Volumes have increased every year, exceeding surgical aortic valve replacement in 2019 (72,991 vs. 57,626), and it is now performed in all U.S. states. TAVR now extends from extreme- to low-risk patients. This is the first presentation on 8,395 low-risk patients treated in 2019. In 2019, for the entire cohort, femoral access increased to 95.3%, hospital stay was 2 days, and 90.3% were discharged home. Since 2011, the 30-day mortality rate has decreased (7.2% to 2.5%), stroke has started to decrease (2.75% to 2.3%), but pacemaker need is unchanged (10.9% to 10.8%). Alive with acceptable patient-reported outcomes is achieved in 8 of 10 patients at 1 year. The Registry is a national resource to improve care and analyze TAVR's evolution. Real-world outcomes, site performance, and the impact of coronavirus disease 2019 will be subsequently studied. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528)., Competing Interests: Author Relationship With Industry Dr. Carroll has been a local investigator for clinical trials sponsored by Edwards Lifesciences, Medtronic, and Abbott; and has been a consultant to Abbott. Dr. Mack has had nonremunerative positions of clinical trial leadership at Edwards Lifesciences, Medtronic, and Abbott. Dr. Vemulapalli has received grants/contracts from the American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health, Patient Centered Outcomes Research Institute, Food and Drug Administration (NESTcc), Boston Scientific, and Abbott Vascular; and has been a consultant/Advisory Board member for Boston Scientific, Janssen, and HeartFlow. Dr. Herrmann has received institutional research grants from Abbott Vascular, Bayer, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr. Gleason has been a member of the Medical Advisory Board for Abbott. Dr. Hanzel has been the local site principal investigator for trials sponsored by Edwards Lifesciences, Abbott, and Boston Scientific. Dr. Deeb has been the local site principal investigator in the Medtronic International TAVR clinical trials. Dr. Thourani has been an advisor to or received research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Gore Vascular, and JenaValve. Dr. Cohen has received research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received consulting income from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr. Desai has been an advisor to or received research grants from Gore, Medtronic, and Terumo. 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); 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. Masoudi has had a contract with the American College of Cardiology for his role as chief scientific advisor, NCDR. Dr. Brindis is senior medical officer, EXTERNAL AFFAirs–ACC National Cardiovascular Data Registry. Dr. Bavaria has been a local investigator for TAVR clinical trials sponsored by Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific; and has been a consultant to Edwards Lifesciences and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 Society of Thoracic Surgeons and the American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Evaluating the hemodynamic performance of aortic valve prostheses has relied primarily on echocardiography. This involves calculating the trans-prosthetic valve mean gradient (MG) and aortic valve area (AVA), and assessing for valvular and paravalvular regurgitation in a fashion similar to the native aortic valve. In conjunction with other echocardiographic and nonechocardiographic parameters, MG and AVA are used to distinguish between prosthesis stenosis, prosthesis patient mismatch, pressure recovery, increased flow, and measurement errors. This review will discuss the principles and limitations of echocardiographic evaluation of aortic valve prosthesis following surgical, and transcatheter aortic valve replacement and in comparison to invasive hemodynamics through illustrative clinical cases., (© 2020 Wiley Periodicals, Inc.)

Background: Invasive fractional flow reserve (FFR INV ) is the standard technique for assessing myocardial ischemia. Pressure distortions and measurement location may influence FFR INV interpretation. We report a technique for performing invasive fractional flow reserve (FFR INV ) by minimizing pressure distortions and identifying the proper location to measure FFR INV ., Methods: FFR INV recordings were obtained prospectively during manual hyperemic pullback in 100 normal and diseased coronary arteries with single stenosis, using 4 measurements from the terminal vessel, distal-to-the-lesion, proximal vessel, and guiding catheter. FFR INV profiles were developed by plotting FFR INV values ( y -axis) and site of measurement ( x -axis), stratified by stenosis severity. FFR INV ≤0.8 was considered positive for lesion-specific ischemia., Results: Erroneous FFR INV values were observed in 10% of vessels because of aortic pressure distortion and in 21% because of distal pressure drift; these were corrected by disengagement of the guiding catheter and re-equalization of distal pressure/aortic pressure, respectively. There were significant declines in FFR INV from the proximal to the terminal vessel in normal and stenotic coronary arteries ( P <0.001). The rate of positive FFR INV was 41% when measured from the terminal vessel and 20% when measured distal-to-the-lesion ( P <0.001); 41.5% of positive terminal measurements were reclassified to negative when measured distal-to-the-lesion. Measuring FFR INV 20 to 30 mm distal-to-the-lesion (rather than from the terminal vessel) can reduce errors in measurement and optimize the assessment of lesion-specific ischemia., Conclusions: Meticulous technique (disengagement of the guiding catheter, FFR INV pullback) is required to avoid erroneous FFR INV , which occur in 31% of vessels. Even with optimal technique, FFR INV values are influenced by stenosis severity and the site of pressure measurement. FFR INV values from the terminal vessel may overestimate lesion-specific ischemia, leading to unnecessary revascularization.

Background: During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions., Methods: We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital., Results: Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40)., Conclusions: An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.)., (Copyright © 2019 Massachusetts Medical Society.)

Objectives: We sought to evaluate the patterns of use and outcomes associated with eptifibatide and abciximab administration among dialysis patients who underwent percutaneous coronary intervention (PCI)., Background: Contraindicated medications are frequently administered to dialysis patients undergoing PCI often resulting in adverse outcomes. Eptifibatide is a glycoprotein IIb/IIIa inhibitor that is often used during PCI and is contraindicated in dialysis., Methods: We included dialysis patients who underwent PCI from January 2010 to September 2015 at 47 hospitals in Michigan. We compared outcomes between patients who received eptifibatide compared with abciximab. Both groups required concurrent treatment with unfractionated heparin only. In-hospital outcomes included repeat PCI, bleeding, major bleeding, need for transfusion, and death. Optimal full matching was used to adjust for non-random drug administration., Results: Of 177 963 patients who underwent PCI, 4303 (2.4%) were on dialysis. Among those, 384 (8.9%) received eptifibatide and 100 (2.3%) received abciximab. Prior to matching, patients who received eptifibatide had higher pre-procedural hemoglobin levels (11.3 g/dL vs. 10.7 g/dL; P < 0.001) and less frequently had a history of myocardial infarction (36.5% vs. 52.0%; P = 0.005). After matching, there were no significant differences in in-hospital outcomes between eptifibatide and abciximab including transfusion (aOR: 1.15; 95%CI: 0.55-2.40; P = 0.70), bleeding (1.47; 0.64-3.40; P = 0.36), major bleeding (4.68; 0.42-52.3; P = 0.21), repeat PCI (0.38; 0.03-4.23; P = 0.43), and death (1.53; 0.2-9.05; P = 0.64)., Conclusions: Despite being contraindicated in dialysis, eptifibatide was used approximately 3.5 times more frequently than abciximab among dialysis patients undergoing PCI but was associated with similar in-hospital outcomes., (© 2017, Wiley Periodicals, Inc.)

Background: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services., Objectives: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States., Methods: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry., Results: The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p < 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p < 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%., Conclusions: The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies., (Copyright © 2017 American College of Cardiology Foundation and The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The purpose of this study was to evaluate the frequency and temporal trends in use of transradial access (TRA) for percutaneous coronary intervention (PCI) in ST-segment-elevation myocardial infarction (STEMI). The use of TRA has been associated with less bleeding and improved clinical outcomes in patients undergoing PCI for STEMI., Methods and Results: The frequency of TRA compared with transfemoral access for patients undergoing PCI for STEMI or other indications (non-ST-segment-elevation myocardial infarction, unstable angina, and non-acute coronary syndrome) in The Blue Cross Blue Shield of Michigan Cardiovascular Consortium database between 2010 and 2013 was evaluated. Propensity matching was used to assess the relationship of TRA with in-hospital clinical end points of major bleeding, transfusion, and death. The TRA cohort of patients was stratified into deciles based on their predicted bleeding risk and compared with PCI indication. Of 122,728 PCI procedures, 17,912 (14.6%) were via TRA. Among patients with STEMI cases, 8.3% of the PCI cases were performed via TRA. The use of TRA increased over the study period although the growth was slower for STEMI than for other indications, P<0.001. The use of TRA for PCI in STEMI was associated with a lower rate of bleeding (11.7% versus 20.0%; P<0.001) and vascular complications (0.7% versus 2.6%; P=0.001), but no mortality difference (1.25% versus 2.33%; P=0.175). There was a strong negative association between the predicted risk of bleeding and the use of TRA (P<0.001)., Conclusions: The use of radial access for PCI in STEMI is increasing but at a slower pace than for patients with other indications. TRA was associated with a reduction in bleeding and transfusion, but there is a strong negative correlation between the predicted risk of bleeding and actual use of TRA in STEMI., (© 2015 American Heart Association, Inc.)

In patients with aortic stenosis (AS) and eccentric transaortic flow, greater pressure loss occurs as the jet collides with the aortic wall together with delayed and diminished pressure recovery. This leads to the elevated transaortic valve pressure gradients noted on both Doppler and cardiac catheterization. Such situations may present a diagnostic dilemma where traditional measures of stenosis severity indicate severe AS, while imaging modalities of the aortic valve geometric aortic valve area (GOA) suggest less than severe stenosis. In this study, we present a series of cases exemplifying this clinical dilemma and demonstrate how color M-mode, 2D and 3D transthoracic (TTE) and transesophageal (TEE) echocardiography, cardiac computed tomography angiography (CTA), and magnetic resonance imaging (MRI), may be used to resolve such discrepancies., (© 2014, Wiley Periodicals, Inc.)

A 49-year-old man underwent emergent coronary angiography for acute inferior myocardial infarction (MI). After balloon angioplasty of culprit right coronary artery (RCA) occlusion, a Promus Element stent would not advance to the target lesion. The proximal end of the stent became compressed against the tip of the guiding catheter, such that the stent could neither be advanced nor withdrawn. This case illustrates the technical aspects of snare removal of a severely deformed stent via the radial artery.

Background and Aim of the Study: Mitral regurgitation (MR) is frequently present in patients with calcific aortic stenosis (AS). Yet, the issue of whether to surgically correct the MR during aortic valve replacement (AVR) remains uncertain. The study aim was to define the outcome of MR after transcatheter aortic valve implantation (TAVI) in the TRanscatheter EndoVascular Implantation of VALves (REVIVAL) II trial., Methods: Echocardiography was performed before and at 24 h, and three and six months after valve implantation. The degree of MR was evaluated by expert readers and by the vena contracta (VC) method. Significant MR was defined as at least mild to moderate MR. Those patients with a 30% reduction in VC were classified as good responders (GR group), and the remainder as poor responders (PR group)., Results: The study comprised 35 subjects with at least mild to moderate MR before TAVI. The mean VC of the whole group declined from 0.5 +/- 0.2 cm initially to 0.32 +/- 0.2 cm and 0.38 +/- 0.2 cm at 24 h and three months, respectively (p < 0.05). At three months, 12 patients had > 30% VC reduction; these constituted the GR group, while the remainder constituted the PR group. The percentage of patients with mitral annular calcification with restriction (MACr), defined as calcification encroaching onto the leaflets and restricting leaflet motion, was significantly lower in the GR group compared to the PR group (17% versus 61%, respectively; p < 0.05). The remaining pre-specified parameters did not differ significantly between the GR and PR groups, including age, gender, mitral valve tethering height and area (6 +/- 2 mm versus 5 +/- 3 mm and 10 +/- 4 mm2 versus 13 +/- 9 and 10 +/- 4 mm2, respectively), change in the aortic valve area (336 +/- 130% versus 285 +/- 180%), change in mean systolic aortic valve pressure (-20 +/- 8% versus - 23 +/- 10%), and left ventricular ejection fraction (47 +/- 15% versus 45 +/- 18%)., Conclusion: MR is improved significantly after TAVI for AS. MACr was the only variable associated with a reduction in MR improvement. These results suggest that a careful echocardiographic evaluation of the mitral valve prior to TAVI may help to predict which patients should experience an improvement in their MR.

Transcatheter aortic valve implantation (TAVI) with the Cribier-Edwards prosthesis may provide an alternative to conventional aortic valve replacement in high-risk patients with aortic stenosis. Previous studies have indicated that TAVI is feasible in this patient population. Transcatheter implantation of a Cribier-Edwards prosthesis was attempted in 55 patients in a United States Food and Drug Administration-approved prospective observational study. Clinical and echocardiographic outcomes were assessed in hospital and at 30 days, 6 months, and 12 months. Fifty-five patients (55% women, mean age 83 years) with a mean aortic valve area of 0.57 ± 0.14 cm(2) and a mean logistic European System for Cardiac Operative Risk Evaluation score of 33.5 ± 17.0% were enrolled. Transcatheter heart valves were implanted successfully in 48 patients (87%). Mean echocardiographic aortic valve area improved from 0.56 ± 0.14 to 1.6 ± 0.48 cm(2) after the procedure (p <0.0001). Thirty-day all-cause mortality and major adverse cardiac and cerebrovascular events were 7.3% and 20%, respectively. There were also 7 major procedural vascular complications (12.7%). Mortality and major adverse cardiac and cerebrovascular events increased to 23.6% and 32.7%, respectively, at 1 year, with most late events related to underlying co-morbidities. Mean New York Heart Association functional class improved from 3.22 ± 0.66 at baseline to 1.50 ± 0.85 at 1 year follow-up (p <0.001). In conclusion, TAVI in high-risk patients with aortic stenosis was feasible, with sustained clinical benefit at 12 months. Procedural complications and late major adverse cardiac and cerebrovascular events, however, overshadowed the overall clinical benefit of TAVI in this high-risk patient population., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Sixty-six patients with atherosclerotic renal artery stenosis (RAS) and serum creatinine < or =2.0 mg/dl were treated with antihypertensive therapy, a statin, and aspirin. Renal stenting was reserved for patients with injuries to the heart, brain, or kidneys. The primary end point was stenotic kidney glomerular filtration rate (GFR) at 21 months; secondary end points included major adverse clinical events, serum creatinine, total GFR, and blood pressure (BP). After baseline evaluation, 26 of 66 patients underwent renal stenting because of injuries to the heart, brain, or kidneys. After 21 months, 6 medical patients required renal stenting, and 5 patients experienced late clinical events (2 medical patients, 3 stent patients). There was no difference in final BP between groups. Whereas medical patients experienced 6% and 8% decreases in total and stenotic kidney GFR, stent patients experienced 7% and 11% increases in total kidney (p = 0.006) and stenotic kidney (p = 0.02) GFR. There was no difference in final serum creatinine. In conclusion, patients with atherosclerotic RAS and baseline creatinine < or =2.0 mg/dl can be safely managed with aggressive medical therapy, with a small decrease in GFR. For patients who develop injuries to the heart, brain, or kidneys, renal artery stenting may further reduce hypertension and improve renal function.