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Background: Prior studies of aortic valve replacement (AVR) in patients with normal-flow, low-gradient aortic stenosis (NF-LG AS) have demonstrated conflicting results regarding the survival benefit of AVR. Changes in quality of life (QoL) after transcatheter AVR (TAVR) have not been reported in this population., Objectives: The purpose of this study was to compare changes in QoL after TAVR for patients with NF-LG AS to patients with high-gradient aortic stenosis (HG-AS)., Methods: Patients who underwent TAVR for severe aortic stenosis (AS) were divided into 4 hemodynamic profiles of AS, including NF-LG AS. Changes in Kansas City Cardiomyopathy Questionnaire-12 score from baseline to 1 year were compared between AS groups. The primary composite outcome indicating clinical improvement consisted of survival to 1 year and improved Kansas City Cardiomyopathy Questionnaire overall summary score of ≥5 points while adjusting for relevant baseline factors., Results: Out of 860 patients who underwent TAVR, high gradient AS was present in 368 (42.8%) patients and NF-LG AS in 245 (28.5%). HG-AS and NF-LG AS groups had a similar proportion of patients who met the primary unadjusted outcome of clinical improvement (70.4% vs 63.9%, respectively; P = 0.189). One-year Kaplan-Meier mortality estimates were higher for NF-LG AS patients than HG-AS patients (12.9% vs 5.8%, P  < 0.001). In the primary adjusted analysis, there was no significant difference in the composite outcome between HG and NF-LG AS groups (adjusted OR: 0.72, 95% CI: 0.47-1.11)., Conclusions: Selected patients with NF-LG AS experienced similar improvement in QoL after TAVR compared with HG-AS. Further investigation of patients with NF-LG AS will help to inform optimal selection for treatment with TAVR., Competing Interests: Dr Fukuhara is a consultant for Terumo Aortic. Dr Chetcuti has received grant support and sponsorship from 10.13039/100006520Edwards Lifesciences, 10.13039/100008497Boston Scientific, and 10.13039/100004374Medtronic has received research sponsorship from St. Jude Medical; and has received proctoring fees from and served as a consultant for Medtronic. Dr Grossman has received grant support from 10.13039/100006520Edwards Lifesciences, 10.13039/100008497Boston Scientific, and 10.13039/100004374Medtronic; and has received proctoring fees from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2023 The Authors.)

Background: Cardiac rehabilitation (CR) is strongly recommended for a spectrum of cardiovascular conditions and procedures including aortic valve replacement., Objectives: The purpose of this study was to characterize patient and hospital factors associated with CR participation after transcatheter aortic valve replacement (TAVR) and determine which factors explain hospital-level variation in CR participation., Methods: We linked clinical and administrative claims data from patients who underwent TAVR at 24 Michigan hospitals between January 1, 2016 and June 30, 2020 and obtained rates of CR enrollment within 90 days of discharge. Sequential mixed models were fit to evaluate hospital variation in 90-day post-TAVR CR participation., Results: Among 3,372 patients, 30.6% participated in CR within 90-days after discharge. Several patient factors were negatively associated with CR participation after TAVR including older age, Medicaid insurance, atrial fibrillation/flutter, dialysis use, and slower baseline 5-m walk times. There was substantial hospital variation in CR participation after TAVR ranging from 5% to 60% across 24 hospitals. Patient case mix did not explain hospital variation in CR across hospitals with median OR numerically increasing from 2.11 (95% CI: 1.62-2.67) to 2.13 (95% CI: 1.61-2.68) after accounting for patient-level factors., Conclusions: Less than 1 in 3 patients who underwent TAVR in Michigan participated in CR within 90-days of discharge. Although several patient factors are associated with CR participation, hospital-level variation in CR participation after TAVR is not explained by patient case mix. Identifying hospital processes of care that promote CR participation after TAVR will be critical to improving CR participation after TAVR., Competing Interests: Support for the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) and the Michigan Value Collaborative (MVC) is provided by 10.13039/100001502Blue Cross Blue Shield of Michigan as part of the Blue Cross Blue Shield of Michigan Value Partnerships program; however, the opinions, beliefs and viewpoints expressed by the authors do not necessarily reflect those of Blue Cross Blue Shield of Michigan or any of its employees. Drs Sukul and Albright have received salary support from the Blue Cross Blue Shield of Michigan for their role in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Dr Thompson has received salary support from Blue Cross Blue Shield of Michigan for his role with the Michigan Value Collaborative and receives funding from the 10.13039/100000133Agency for Healthcare Research and Quality (K01HS027830). Drs Patel, Chetcuti, and Grossman have received salary support for their role in the Michigan Structural Heart Consortium. Dr Villablanca is a consultant for Edwards, Teleflex, and Angiodynamics; and a proctor for Edwards. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited., Objectives: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience., Methods: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported., Results: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001)., Conclusions: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important., Competing Interests: Funding Support and Author Disclosures Dr Attizzani is a consultant for Medtronic and Abbott Vascular; and serves as a proctor and is on the advisory board for Medtronic. Dr Chetcuti has received personal fees from Medtronic for proctoring and consulting; institutional grants from Edwards Lifesciences, Boston Scientific, and Jena during the conduct of the study; and serves on advisory boards for JenaValve without remuneration. Dr Fukuhara is a consultant for Medtronic, Terumo Aortic, and Artivion. Dr Grossman is a physician proctor for Medtronic; and receives research support from Medtronic, Edwards Lifesciences, Abbott, Cardiovascular Systems, Inc., and Boston Scientific. Dr Goel is a consultant for Medtronic and W. L. Gore & Associates; and is on the Speakers Bureau for Abbott Structural Heart. Dr Kleiman is a local principal investigator in trials sponsored by Boston Scientific, Medtronic, Abbott, and Edwards Lifesciences. Dr Puri is a speaker and proctor for Medtronic; is a consultant for Medtronic, Centerline Biomedical, Boston Scientific, Abbott, Philips, Products & Features, Shockwave Medical, VDyne, VahatiCor, Advanced Nanotherapies, NuevoSono, TherOx, GE Healthcare, BioVentrix, and Protembis; and has equity interest in Centerline Biomedical, VahatiCor, and NuevoSono. Dr Byrne is a physician proctor for Abbott Structural Heart and Medtronic; a consultant for Medtronic and Abiomed; and has received speakers honoraria from Abbott Structural Heart and Abiomed. Dr Grubb is a physician proctor for Medtronic and Edwards Lifesciences; and has served as a consultant for Medtronic, Boston Scientific, Ancora, HLT, BioVentrics, 4C Medical, W.L. Gore, and Abbott Vascular. Dr Herrmann has received institutional research funding from Boston Scientific, Abbott Structural Heart, Edwards Lifesciences, and Medtronic; and has received consultant fees and speaking honoraria from Medtronic. Dr Ramlawi is a consultant for Boston Scientific, Medtronic, Liva Nova, and Atricure. 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 Reardon is a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. 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 speakers honoraria from Siemens Healthineers and East End Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Despite the rapid adoption of transcatheter aortic valve replacement since its approval, the frequency and outcomes of aortic valve reintervention after transcatheter aortic valve replacement are poorly understood., Methods: Valve reinterventions, either surgical transcatheter aortic valve explantation or repeat transcatheter aortic valve replacement, between 2012 and 2019 were queried using the Society of Thoracic Surgeons Database and the Transcatheter Valve Therapy Registry through the Michigan Statewide quality collaborative. The reintervention frequency and clinical outcomes including observed-to-expected mortality ratio using Society of Thoracic Surgeons Predicted Risk of Mortality were reviewed., Results: Among 9694 transcatheter aortic valve replacement recipients, a total of 87 patients (0.90%) received a reintervention, consisting of 34 transcatheter aortic valve explants and 53 repeat transcatheter aortic valve replacement procedures. The transcatheter aortic valve explant group demonstrated a higher Society of Thoracic Surgeons Predicted Risk of Mortality. Reintervention cases increased from 0 in 2012 and 2013 to 26 in 2019. The proportion of transcatheter aortic valve explants among all reinterventions increased and was 65% in 2019. Self-expandable devices had a higher reintervention rate than balloon-expandable devices secondary to a higher transcatheter aortic valve explant frequency (0.58% [23/3957] vs 0.19% [11/5737]; P = .001), whereas repeat transcatheter aortic valve replacement rates were similar (0.61% [24/3957] vs 0.51% [29/5737]; P = .51). Among patients with transcatheter aortic valve explants, contraindications to repeat transcatheter aortic valve replacement included unfavorable anatomy (75%), need for other cardiac surgery (29%), other structural issues by transcatheter aortic valve device (18%), and endocarditis (12%). For transcatheter aortic valve explant and repeat transcatheter aortic valve replacement, the 30-day mortality was 15% and 2% (P = .032) and the observed-to-expected mortality ratio was 1.8 and 0.3 (P = .018), respectively., Conclusions: Aortic valve reintervention remains rare but is increasing. The clinical impact of surgical device explantation was substantial, and the proportion of transcatheter aortic valve explants was significantly higher in patients with a self-expandable device., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Aortic stenosis treatment should consider risks and benefits for lifetime management. Although the feasibility of redo transcatheter aortic valve replacement (TAVR) remains unclear, concerns are emerging regarding reoperation after TAVR., Objectives: The authors sought to define comparative risk of surgical aortic valve replacement (SAVR) after prior TAVR or SAVR., Methods: Data on patients undergoing bioprosthetic SAVR after TAVR and/or SAVR were extracted from the Society of Thoracic Surgeons Database (2011-2021). Overall and isolated SAVR cohorts were analyzed. The primary outcome was operative mortality. Risk adjustment using hierarchical logistic regression as well as propensity score matching for isolated SAVR cases were performed., Results: Of 31,106 SAVR patients, 1,126 had prior TAVR (TAVR-SAVR), 674 had prior SAVR and TAVR (SAVR-TAVR-SAVR), and 29,306 had prior SAVR (SAVR-SAVR). Yearly rates of TAVR-SAVR and SAVR-TAVR-SAVR increased over time, whereas SAVR-SAVR was stable. The TAVR-SAVR patients were older, with higher acuity, and with greater comorbidities than other cohorts. The unadjusted operative mortality was highest in the TAVR-SAVR group (17% vs 12% vs 9%, respectively; P < 0.001). Compared with SAVR-SAVR, risk-adjusted operative mortality was significantly higher for TAVR-SAVR (OR: 1.53; P = 0.004), but not SAVR-TAVR-SAVR (OR: 1.02; P = 0.927). After propensity score matching, operative mortality of isolated SAVR was 1.74 times higher for TAVR-SAVR than SAVR-SAVR patients (P = 0.020)., Conclusions: The number of post-TAVR reoperations is increasing and represent a high-risk population. Yet even in isolated SAVR cases, SAVR after TAVR is independently associated with increased risk of mortality. Patients with life expectancy beyond a TAVR valve and unsuitable anatomy for redo-TAVR should consider a SAVR-first approach., Competing Interests: Funding Support and Author Disclosures The data for this research were provided by The Society of Thoracic Surgeons’ National Database Participant User File Research Program. Data analysis was performed at the investigators’ institution. This work was funded by the Family of Harpreet and Sangeeta Ahluwalia Fund. Dr Patel has received consulting fees from Medtronic, Terumo, and W.L. Gore. Dr Chetcuti has received consulting fees from Medtronic. Dr Ailawadi has received consulting fees from Abbott Vascular, Medtronic, Edwards Lifesciences, W.L. Gore, Cephea, Admedus, Philips, and Johnson & Johnson. Dr Fukuhara has received consulting fees from Terumo, Medtronic, and Artivion. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The 30-day rate of stroke after transcatheter aortic valve replacement (TAVR) has been suggested as a hospital quality metric. Thirty-day stroke rates for nonsurgical, high, and moderate-risk TAVR trials were 3.4% to 6.1%, whereas those in the national Transcatheter Valve Therapy (TVT) Registry for the same patient population were much lower. Hospital comprehensive stroke center (CSC) is the highest designation for integrated acute stroke recognition, management, and care., Objectives: Using Michigan TVT data, we assessed whether in-hospital post-TAVR stroke rates varied between CSC and non-CSC institutions., Methods: TVT data submitted from the 22 Michigan Transcatheter Aortic Valve Replacement Collaborative participating institutions between January 1, 2016, and June 30, 2019, were included (N = 6,231). Bayesian hierarchical regression models accounting for patient clinical characteristics and hospital clustering were fitted to assess the association between hospital CSC accreditation and in-hospital post-TAVR stroke. Adjusted ORs and 95% credible intervals were estimated. The University of Michigan Institutional Review Board has waived the need for the approval of studies based on the data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry., Results: There were 3,882 (62.3%) patients at 9 CSC sites and 2,349 (37.7%) patients at 13 non-CSC sites. CSC sites had significantly higher rates of in-hospital post-TAVR stroke (CSC: 2.65% vs non-CSC: 1.15%; P < 0.001). After adjustment, patients who underwent TAVR at a CSC hospital had a significantly higher risk of in-hospital stroke (adjusted OR: 2.21; 95% CI: 1.03-4.62). However, CSC designation was not significantly associated with other important post-TAVR clinical outcomes including 30-day mortality., Conclusions: Reported Michigan Transcatheter Aortic Valve Replacement Collaborative TVT stroke rates were significantly higher at sites with Joint Hospital Commission stroke designation status; however, other reported important clinical outcomes did not differ significantly based on this designation. CSC designation is a possible factor in stroke rate detection differences between TAVR institutions and might be a factor in the observed differences in stroke rates between TAVR trials and those reported in TVT. In addition, these data suggest that comparison between hospitals based on post-TAVR stroke rates is potentially problematic., Competing Interests: Funding Support and Author Disclosures Michigan TAVR is supported by Blue Cross Blue Shield of Michigan. Dr Grossman is a consultant for Medtronic Cardiovascular and Edwards Lifesciences; provides research support for Medtronic Cardiovascular, Edwards Lifesciences; Cardiovascular Systems Inc, and National Institutes of Health; and provides registry support for Blue Cross Blue Shield of Michigan. Dr Sukul provides registry support for Blue Cross Blue Shield of Michigan. Dr Seth provides registry support for Blue Cross Blue Shield of Michigan. Dr Chetcuti is a consultant for Medtronic Cardiovascular and Edwards Lifesciences; provides research support for Medtronic Cardiovascular and Edwards Lifesciences; and provides registry support for Blue Cross Blue Shield of Michigan. Dr Patel provides registry support from Blue Cross Blue Shield of Michigan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Left bundle branch block (LBBB) and atrioventricular (AV) conduction abnormalities requiring permanent pacemaker (PPM) implantation occur frequently following transcatheter aortic valve replacement (TAVR). The resultant left ventricular (LV) dyssynchrony may be associated with adverse clinical events., Objectives: The purpose of this study was to assess the adverse outcomes associated with LV dyssynchrony due to high-burden right ventricular (RV) pacing or permanent LBBB following TAVR in patients with preserved left ventricular ejection fraction (LVEF)., Methods: Consecutive TAVR patients at the University of Michigan from January 2012 to June 2017 were included. Pre-existing cardiac implantable electronic device, previous LBBB, LVEF <50%, or follow-up period <1 year were excluded. The primary outcome was all-cause mortality. Secondary outcomes included cardiomyopathy (defined as LVEF ≤45%), a composite endpoint of cardiomyopathy or all-cause mortality, and the change in LVEF at 1-year follow-up., Results: A total of 362 patients were analyzed (mean age 77 years). LV dyssynchrony group (n = 91 [25.1%]) included 56 permanent LBBB patients, 12 permanent LBBB patients with PPM, and 23 non-LBBB patients with PPM and high-burden RV pacing. Remaining patients served as control (n = 271 [74.9%]). After adjusted analysis, LV dyssynchrony had significantly higher all-cause mortality (adjusted hazard ratio [HR] 2.16; 95% confidence interval [CI] 1.07-4.37) and cardiomyopathy (adjusted HR 14.80; 95% CI 6.31-14.69). The LV dyssynchrony group had mean LVEF decline of 10.5% ± 10.2% compared to a small increase (0.5% ± 7.7%) in control., Conclusion: Among TAVR patients with preserved LVEF and normal AV conduction, development of postprocedural LV dyssynchrony secondary to high-burden RV pacing or permanent LBBB was associated with significantly higher risk of death and cardiomyopathy at 1-year follow-up., (Copyright © 2022. Published by Elsevier Inc.)

Background: Aortic regurgitation (AR) is common and detrimental in patients with left ventricular assist devices (LVADs). Off-label use of transcatheter aortic valve replacement (TAVR) has emerged as a potential treatment option. Further data are required regarding the feasibility and outcomes of TAVR to treat AR in LVAD recipients., Methods: A retrospective review of all patients with LVADs who underwent TAVR for the treatment of AR at a single center was performed. All echocardiograms were independently reviewed to ensure accuracy., Results: Eleven patients with continuous-flow LVADs underwent TAVR for AR. All patients had moderate or severe AR with New York Heart Association (NYHA) class III and IV symptoms. Implantation of more than 1 valve was required in 4 (36.3%) patients; 1 patient died during the procedure because of valve migration into the left ventricle and 1 patient died in-hospital after TAVR. Of 9 (81.8%) patients discharged alive, 8 (72.7%) were alive at 12 months and all survivors had improvement in AR severity, natriuretic peptide levels, left ventricle end-diastolic diameter, and NYHA class. Five (62.5%) survivors had a large improvement (>20 points) in the Kansas City Cardiomyopathy Questionnaire score at 1 year. One survivor experienced heart failure, requiring hospitalization, within 1 year., Conclusions: In this single-center series, TAVR for the treatment of AR in patients with LVADs is technically challenging but feasible in select patients and may produce durable improvements in AR severity, functional status, and quality of life.

Background P2Y12 inhibitor medications are critical following percutaneous coronary intervention (PCI); however, adherence remains suboptimal. Our objective was to assess the effectiveness of a multifaceted intervention to improve P2Y12 inhibitor adherence following PCI. Methods and Results This was a modified stepped wedge trial of 52 eligible hospitals, of which 15 were randomly selected and agreed to participate (29 hospitals declined, and 8 eligible hospitals were not contacted). At each intervention hospital, patient recruitment occurred for 6 months and enrolled patients were followed up for 1 year after PCI. Three control groups were used: patients at intervention hospitals undergoing PCI (1) before the intervention period (preintervention); (2) after the intervention period (postintervention); or (3) at the 8 hospitals not contacted (concurrent controls). The intervention consisted of 4 components: (1) P2Y12 inhibitor delivered to patients' bedside after PCI; (2) education on importance of P2Y12 inhibitors; (3) automated reminder telephone calls to refill medication; and (4) outreach to patients if they delayed refilling P2Y12 inhibitor. The primary outcomes were as follows: (1) proportion of patients with delays filling P2Y12 inhibitor at hospital discharge and (2) proportion of patients who were adherent in the year after PCI using pharmacy refill data. Primary analysis compared intervention with preintervention control patients. There were 1377 (intent-to-treat) potentially eligible patients, of whom 803 (per protocol) were approached at intervention sites versus 5910 preintervention, 2807 postintervention, and 4736 concurrent control patients. In the intent-to-treat analysis, intervention patients were less likely to delay filling P2Y12 at hospital discharge (-3.4%; 98.3% CI, -1.2% to -5.6%) and more likely to be adherent to P2Y12 (4.1%; 98.3% CI, 1.0%-7.1%) at 1 year, but had more clinical events (3.2%; 98.3% CI, 2.3%-4.1%) driven by repeated PCI compared with preintervention patients. In post hoc analysis looking at myocardial infarction, stroke, and death, intervention patients had lower event rates compared with preintervention patients (-1.7%; 98.3% CI, -2.3% to -1.1%). Conclusions A 4-component intervention targeting P2Y12 inhibitor adherence was difficult to implement. The intervention produced mixed results. It improved P2Y12 adherence, but there was also an increase in repeat PCI. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609842.

Background: Acute kidney injury (AKI) after contrast-guided interventions is associated with adverse outcomes, but the role of contrast in the context of renal function is less well described for patients undergoing transcatheter aortic valve replacement (TAVR)., Methods: Patients from the Michigan TAVR registry between January 2016 and December 2019 were included. AKI was defined using Valve Academic Research Consortium 2 definitions. An integer cut point for the ratio of contrast volume (CV) to renal function (estimated glomerular filtration rate [eGFR]) as a predictor of AKI was calculated., Results: Of 7112 cases, AKI occurred in 629 (8.8%) patients. Unadjusted mortality was higher among patients with AKI (32.5% vs 9.0%, P  ​< ​.0001). AKI remained significantly associated with the risk of mortality after multivariable adjustment (hazard ratio = 4.50, P  ​< ​.001). Procedural characteristics associated with AKI included CV/eGFR >2 (adjusted odds ratio [aOR] = 1.36, P = .003, 95% CI = 1.10-1.67), CV/eGFR >3 (aOR = 1.38, P  ​= ​.009, 95% CI = 1.09-1.77), and use of general anesthesia (aOR = 1.67, P  ​< ​.0001, 95% CI = 1.38-2.03)., Conclusions: CV in the context of renal function administrated during TAVR is a robust tool to predict AKI. AKI after TAVR is associated with an increased risk of mortality. Incorporation of thresholds of >2× and > 3× eGFR into procedural planning should be considered as a quality initiative., Competing Interests: S. Gualano, W. Merhi, C. Schwartz, and F. Shannon have no disclosures. S. Chetcuti has been a consultant and proctor for Medtronic, with research support from 10.13039/100004374Medtronic, Gore, 10.13039/100008497Boston Scientific, 10.13039/100006520Edwards Lifesciences, and JenaValve. D. Sukul receives research funding from 10.13039/100001502Blue Cross Blue Shield of Michigan. H. Patel is a consultant for Medtronic and WL Gore. H. Gurm receives research funding from 10.13039/100001502Blue Cross Blue Shield of Michigan and the 10.13039/100000002National Institutes of Health Center for Accelerated Innovation and is a consultant for Osprey Medical. W. O’Neill is a consultant for Abbott, Edwards Lifesciences, Boston Scientific, and Abiomed, with research grant support from Abiomed, 10.13039/100001316Abbott, 10.13039/100006520Edwards Lifesciences, and 10.13039/100004374Medtronic. P. Grossman is a consultant for Medtronic Cardiovascular, has research support from 10.13039/100004374Medtronic Cardiovascular, 10.13039/100006520Edwards Life Sciences, and 10.13039/100016476Cardiovascular Systems Incorporated, has registry support from 10.13039/100001502Blue Cross Blue Shield of Michigan, and has research support from 10.13039/100000002National Institutes of Health. None of the authors have any conflicts directly relevant to this study.

The self-expanding transcatheter heart valve (Medtronic Cardiovascular Corevalve and Evolut) is a supra-annular, trileafet porcine pericardial valves on a diamond lattice nickel-titanium alloy frame. The TAVR device has undergone significant improvements in design and procedural techniques to further increase safety, efficacy, and durability since they it was first released. Unique design characteristics, as well as patient and procedural factors, favor self-expanding over balloon-expandable prostheses in certain situations. The self-expanding transcatheter heart valve has proven to be an excellent option for severe aortic stenosis patients with any level of surgical risk and preliminary data suggest a comparable durability to surgical tissue valves., Competing Interests: Disclosure Dr P.M. Grossman: Research support from Medtronic Cardiovascular and Edwards Lifesciences. Physician proctor for Medtronic TAVR and Edwards TAVR., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Despite the rapid adoption of transcatheter aortic valve replacement (TAVR) since its initial approval in 2011, the frequency and outcomes of surgical explantation of TAVR devices (TAVR-explant) is poorly understood., Methods: Patients undergoing TAVR-explant between January 2012 and June 2020 at 33 hospitals in Michigan were identified in the Society of Thoracic Surgeons Database and linked to index TAVR data from the Transcatheter Valve Therapy Registry through a statewide quality collaborative. The primary outcome was operative mortality. Indications for TAVR-explant, contraindications to redo TAVR, operative data, and outcomes were collected from Society of Thoracic Surgeons and Transcatheter Valve Therapy databases. Baseline Society of Thoracic Surgeons Predicted Risk of Mortality was compared between index TAVR and TAVR-explant., Results: Twenty-four surgeons at 12 hospitals performed TAVR-explants in 46 patients (median age, 73). The frequency of TAVR-explant was 0.4%, and the number of explants increased annually. Median time to TAVR-explant was 139 days and among known device types explanted, most were self-expanding valves (29/41, 71%). Common indications for TAVR-explant were procedure-related failure (35%), paravalvular leak (28%), and need for other cardiac surgery (26%). Contraindications to redo TAVR included need for other cardiac surgery (28%), unsuitable noncoronary anatomy (13%), coronary obstruction (11%), and endocarditis (11%). Overall, 65% (30/46) of patients underwent concomitant procedures, including aortic repair/replacement in 33% (n=15), mitral surgery in 22% (n=10), and coronary artery bypass grafting in 16% (n=7). The median Society of Thoracic Surgeons Predicted Risk of Mortality was 4.2% at index TAVR and 9.3% at TAVR-explant (P=0.001). Operative mortality was 20% (9/46) and 76% (35/46) of patients had in-hospital complications. Of patients alive at discharge, 37% (17/37) were discharged home and overall 3-month survival was 73±14%., Conclusions: TAVR-explant is rare but increasing, and its clinical impact is substantial. As the utilization of TAVR expands into younger and lower-risk patients, providers should consider the potential for future TAVR-explant during selection of an initial valve strategy.

Objectives: This multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead., Background: Despite increasing use of temporary cardiac pacing with the rapid growth of structural heart procedures, temporary pacing leads have not significantly improved. The Tempo lead is a new temporary pacing lead with a soft tip intended to minimize the risk of perforation and a novel active fixation mechanism designed to enhance lead stability., Methods: Data from 269 consecutive structural heart procedures were collected. Outcomes included device safety (absence of clinically significant cardiac perforation, new pericardial effusion, or sustained ventricular arrhythmia) and efficacy (clinically acceptable pacing thresholds with successful pace capture throughout the index procedure). Postprocedure practices and sustained lead performance were also analyzed., Results: The Tempo lead was successfully positioned in the right ventricle and achieved pacing in 264 of 269 patients (98.1%). Two patients (0.8%) experienced loss of pace capture. Procedural mean pace capture threshold (PCT) was 0.7 ± 0.8 mA. There were no clinically significant perforations, pericardial effusions, or sustained device-related arrhythmias. The Tempo lead was left in place postprocedure in 189 patients (71.6%) for mean duration of 43.3 ± 0.7 hr (range 2.5-221.3 hr) with final PCT of 0.84 ± 1.04 mA (n = 80). Of these patients, 84.1% mobilized out of bed with no lead dislodgment., Conclusion: The Tempo lead is safe and effective for temporary cardiac pacing for structural heart procedures, provides stable peri and postprocedural pacing and allows mobilization of patients who require temporary pacing leads., (© 2019 Wiley Periodicals, Inc.)

Background: Structural valve degeneration (SVD) is a major flaw of bioprostheses. An apparent increase in the SVD rate has been observed among patients who received the Trifecta bioprosthesis (Abbott Vascular, Santa Clara, CA)., Methods: This study retrospectively reviewed 1058 consecutive patients who underwent aortic valve placement with a stented bioprosthesis between January 2011 and December 2015. Patients were grouped into a Trifecta group (508 [48.0%] patients with Trifecta bioprostheses) and a non-Trifecta group (550 [52.0%] patients with other bioprostheses)., Results: Patients in the Trifecta group were older (69.7 years vs 64.6 years; P = .001), were more likely female (40.4% vs 28.0%; P = .001), more often had aortic stenosis (85.1% vs 77.1%; P = .001), and received smaller valves (23.0 mm vs 25.0 mm; P < .001) than patients in the non-Trifecta group. SVD occurred in 28 patients (Trifecta, n = 22; non-Trifecta, n = 6) within 7 years. Aortic regurgitation or mixed stenosis/regurgitation was observed as the mode of failure in more than 50% of the Trifecta group, whereas none in non-Trifecta group. The cumulative incidence of SVD was higher in the Trifecta group both in the entire cohort (13.3% vs 4.6%; P = .010) and in the younger cohort (age ≤ 65 years; 27.9% vs 6.9%; P = .004), with a notable increase between 5 and 7 years. Multivariable competing risks regression in the Trifecta group revealed younger age (hazard ratio, 0.56 per 10-point decrease; 95% confidence interval, 0.44 to 0.72; P < .001) to be the sole contributor to SVD., Conclusions: The SVD rate of the Trifecta bioprosthesis has been greater than expected, compared with other bioprostheses, particularly in younger patients. In view of the large number of Trifecta bioprostheses implanted worldwide, further investigation involving other institutions is warranted., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to describe clinical and procedural characteristics of veterans undergoing transcatheter aortic valve replacement (TAVR) within U.S. Department of Veterans Affairs (VA) centers and to examine their association with short- and long-term mortality, length of stay (LOS), and rehospitalization within 30 days., Background: Veterans with severe aortic stenosis frequently undergo TAVR at VA medical centers., Methods: Consecutive veterans undergoing TAVR between 2012 and 2017 were included. Patient and procedural characteristics were obtained from the VA Clinical Assessment, Reporting, and Tracking system. The primary outcomes were 30-day and 1-year survival, LOS >6 days, and rehospitalization within 30 days. Logistic regression and Cox proportional hazards analyses were performed to evaluate the associations between pre-procedural characteristics and LOS and rehospitalization., Results: Nine hundred fifty-nine veterans underwent TAVR at 8 VA centers during the study period, 860 (90%) by transfemoral access, 50 (5%) transapical, 36 (3.8%) transaxillary, and 3 (0.3%) transaortic. Men predominated (939 of 959 [98%]), with an average age of 78.1 years. There were 28 deaths within 30 days (2.9%) and 134 at 1 year (14.0%). Median LOS was 5 days, and 141 veterans were rehospitalized within 30 days (14.7%). Nonfemoral access (odds ratio: 1.74; 95% confidence interval [CI]: 1.10 to 2.74), heart failure (odds ratio: 2.51; 95% CI: 1.83 to 3.44), and atrial fibrillation (odds ratio: 1.40; 95% CI: 1.01 to 1.95) were associated with increased LOS. Atrial fibrillation was associated with 30-day rehospitalization (hazard ratio: 1.79; 95% CI: 1.22 to 2.63)., Conclusions: Veterans undergoing TAVR at VA centers are predominantly elderly men with significant comorbidities. Clinical outcomes of mortality and rehospitalization at 30 days and 1-year mortality compare favorably with benchmark outcome data outside the VA., (Published by Elsevier Inc.)

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: P2Y12 inhibitors are critical following percutaneous coronary intervention (PCI) with stent placement; they reduce the risk of stent thrombosis and myocardial infarction. Despite the importance of the therapy, non-adherence is common among Veterans., Methods and Results: Our main objective is to conduct a multi-site randomized stepped wedge trial to test the effectiveness of a multi-faceted intervention to improve adherence to P2Y12 inhibitors and PCI outcomes as well as formatively evaluate and refine the intervention implementation process. The primary outcomes of the study are the proportion of patients whose P2Y12 inhibitor prescription was filled at the time of hospital discharge following PCI with stent placement as well as the proportion of patients who were adherent based on the pharmacy refill data in the year after PCI hospital discharge. We will also assess the secondary outcomes such as bleeding, myocardial infarction, stroke, and mortality among these patients, and the cost-effectiveness of the intervention. The study was conducted at Veterans Health Administration (VA) PCI sites. At each site, we enrolled patients over a 6-month period and followed them for 12 months after PCI. Additionally, we collected qualitative data to identify contextual factors and to assess barriers and facilitators to the implementation and maintenance of the intervention., Conclusions: The study will add to the current state of knowledge on improving medication adherence in patients receiving PCI with stent implantation. Moreover, the study includes an extensive examination of the implementation process and will contribute to the field of implementation science., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01609842 https://clinicaltrials.gov/ct2/show/NCT01609842?term=clopidogrel+adherence&cntry1=NA%3AUS&rank=1., (Published by Elsevier Inc.)

Objectives: The authors sought to compare clinical and hemodynamic outcomes in patients receiving transcatheter aortic valve replacement (TAVR) for low-gradient (LG) aortic stenosis in the CoreValve EUS (Expanded Use Study) versus those with high-gradient (HG) aortic stenosis from the CoreValve U.S. Pivotal Extreme Risk Trial and CAS (Continued Access Study)., Background: The EUS examined the impact of TAVR in patients unsuitable for surgical aortic valve replacement who were excluded from the U.S. Pivotal Extreme Risk Trial due to LG aortic stenosis., Methods: EUS patients were stratified by left ventricular ejection fraction: normal (≥50%, LG-normal ejection fraction), and low (<50%, did not respond to dobutamine by generating a mean gradient >40 mm Hg and/or velocity >4.0 m/s, "nonresponders"), and compared with extreme-risk patients from U.S. Pivotal and CAS that had either low resting gradient and responded to dobutamine ("responders"), or a high resting gradient (HG) or velocity. The primary endpoint was all-cause mortality or major stroke at 1 year. Hemodynamics and quality of life are reported at 30 days and 1 year., Results: At 30 days, patients with LG/low left ventricular ejection fraction (nonresponders and responders) had significantly higher rates of all-cause mortality or major stroke, all-cause mortality, and cardiovascular mortality than both HG and LG-normal ejection fraction patients. At 1 year, only the responders had higher rates of these outcomes in comparison to the other 3 groups. Mean gradient and effective orifice area improved significantly in all patients and were maintained through 1 year. New York Heart Association functional classification and Kansas City Cardiomyopathy Questionnaire overall summary scores improved (p < 0.05) in all cohorts through 1 year. When all 4 subgroups were pooled, both decreasing mean gradient and stroke volume index were associated with increased mortality. Pre-procedural mean gradient was the only hemodynamic independent predictor of 1-year mortality by multivariate analysis., Conclusions: In this study, TAVR provided EUS patients significant hemodynamic relief with both 1-year survival and quality of life outcomes comparable to Pivotal and CAS patients (Safety & Efficacy Study of the Medtronic CoreValve System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement, NCT01675440; Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement, NCT01240902; Safety and Efficacy Continued Access Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement, NCT01531374)., (Copyright © 2019. Published by Elsevier Inc.)

Background: Acute limb ischemia (ALI) of the lower extremity is a potentially devastating condition that requires urgent and definitive management. This challenging scenario is often treated with endovascular, open surgical, or hybrid revascularization (HyR) in an urgent basis, but the comparative effects of such therapies remain poorly defined. The purpose of this study was to compare the outcomes of endovascular, open surgical, and HyR for ALI in the contemporary era., Methods: A large statewide cardiovascular consortium of 45 hospitals was queried for patients between January 2012 and June 2015 who underwent an endovascular, open surgical, or HyR for ALI deemed at high risk of limb loss if not treated within 24 hr (Rutherford class IIA or IIB). A propensity score weighted analysis was performed controlling for demographics, medical history, and procedure type for patients. The primary outcomes were 30-day morbidity and mortality., Results: A total of 1,480 patients underwent endovascular revascularization (ER; n = 818), open surgical revascularization (OSR; n = 195), or hybrid revascularization (HyR; n = 467) for ALI. The mean age was similar across revascularization technique with an increased predominance of male gender in open surgery cohort. Comorbidities for all groups were consistent with peripheral arterial disease. The most common endovascular procedures were angioplasty (93%) and thrombolysis (49.8%), whereas the most common surgical revascularization was femoral to popliteal bypass (32.8%), femoral to tibial bypass (28.2%), and thrombectomy (19.0%); ER as compared with OSR and HyR procedures was associated with less transfusion (OSR versus ER, odds ratio [OR] 2.7; HyR versus ER, OR 2.8; P < 0.001) and major amputation (OSR versus ER, OR 3.4; HyR versus ER, OR 4.0; P < 0.001) within 30 days of intervention. There was no difference in 30-day freedom from reintervention, myocardial infarction (MI), or mortality., Conclusions: Among patients requiring urgent revascularization for Rutherford grade IIA and IIB ischemia, ER has lower 30-day morbidity but similar mortality and rates of reintervention. Although long-term patency rates were not compared, ER may offer superior short-term outcomes compared with open surgery and hybrid revascularization., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: This analysis evaluates the relationship of annular size to hemodynamics and the incidence of prosthesis-patient mismatch (PPM) in surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients., Methods: The CoreValve US Pivotal High Risk Trial, described previously, compared TAVR using a self-expanding valve with SAVR. Multislice computed tomography was used to categorize TAVR and SAVR subjects according to annular perimeter-derived diameter: large (≥26 mm), medium (23 to <26 mm), and small (<23 mm). Hemodynamics, PPM, and clinical outcomes were assessed., Results: At all postprocedure visits, mean gradients were significantly lower for TAVR compared with SAVR in small and medium size annuli (p < 0.001). Annular size was significantly associated with mean gradient after SAVR, with small annuli having the highest gradients (p < 0.05 at all timepoints); gradients were similar across all annular sizes after TAVR. In subjects receiving SAVR, the frequency of PPM was significantly associated with annular size, with small annuli having the greatest incidence. No difference in PPM incidence by annular sizing was observed with TAVR. In addition, TAVR subjects had significantly less PPM than SAVR subjects in small and medium annuli (p < 0.001), with no difference in the incidence of PPM between TAVR and SAVR in large annuli (p = 0.10)., Conclusions: Annular size has a significant effect on hemodynamics and the incidence of PPM in SAVR subjects, not observed in TAVR subjects. With respect to annular size, TAVR results in better hemodynamics and less PPM for annuli less than 26 mm and should be strongly considered when choosing a tissue valve for small and medium size annuli., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the clinical features and outcomes of patients with anemia undergoing percutaneous peripheral vascular intervention (PVI) in a contemporary registry., Methods: We evaluated the differences in the clinical features and outcomes of patients with and without anemia undergoing PVI in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2 VIC) registry. Anemia was defined using World Health Organization criteria., Results: Baseline anemia was present in 42.3% of 15,683 patients undergoing PVI. Compared to patients without anemia, those with anemia were older (mean age, 67 years vs 71 years), were more often black (16% vs 29%), and had higher comorbidities. Anemic patients were twice as likely to present with acute limb ischemia (5% vs 11%) and undergo urgent PVI (6% vs 15%) or below-the-knee PVI (18% vs 35%). Many in-hospital adverse events were higher in anemic patients. In a propensity-matched cohort, any adverse outcome (3.4% vs 8.4%; odds ratio [OR], 2.58; 95% confidence interval [CI], 1.94-3.42) or major cardiovascular event, defined as death, myocardial infarction, stroke, or amputation (1.1% vs 3.2%; OR, 2.96; 95% CI, 1.83-4.79) was more likely in anemic patients. Of all adverse events, the highest odds were observed for post-PVI transfusions and amputations in anemic patients. Multivariable logistic regression showed that baseline hemoglobin (1 g/dL below the normal value) was associated with greater risk of any adverse event (OR, 1.57; 95% CI, 1.47-1.68)., Conclusion: The prevalence of anemia was high among PVI patients and was associated with significantly greater likelihood of amputation, any adverse event, and major cardiovascular events. Whether preprocedure correction of anemia has the potential to decrease post-PVI adverse events remains to be studied.

Objectives: This study sought to describe the distribution of pre-intervention treated-limb ankle-brachial indices (ABIs) among patients with critical limb ischemia (CLI) undergoing percutaneous vascular intervention (PVI) or surgical revascularization (SR)., Background: CLI is diagnosed by the presence of rest pain, tissue ulceration, or gangrene due to chronic arterial insufficiency. It is unclear what fraction of patients with suspected CLI have severe peripheral artery disease (PAD) on noninvasive functional testing., Methods: The study included patients who underwent lower extremity revascularization for CLI in a multicenter registry in Michigan from January 2012 through June 2015. ABIs were classified as normal (ABI: 0.91 to 1.40), mild-moderate (ABI: 0.41 to 0.90), and severe (ABI: ≤0.40). Pre- and post-intervention Peripheral Artery Questionnaire summary scores were assessed in a subset of patients., Results: Among 10,756 patients with signs or symptoms of CLI, 9,113 (84.7%) underwent PVI and 1,643 (15.3%) underwent SR. ABIs were recorded in 4,972 (54.6%) PVI and 1,012 (61.6%) SR patients. Patients undergoing PVI had higher ABIs than those undergoing SR, with substantial variation in both groups (PVI: 0.72 ± 0.29 vs. SR: 0.61 ± 0.29; p < 0.001). Nearly a quarter of patients with compressible arteries had normal ABIs (24.0%), whereas severe PAD was uncommon (16.5%). A significant improvement in Peripheral Artery Questionnaire scores was noted after intervention across all ABI categories., Conclusions: Among patients undergoing revascularization for CLI in contemporary practice, the authors found substantial heterogeneity in pre-intervention ABIs. The disconnect between ABI results and clinical diagnosis calls into question the utility of ABIs in this population and suggests the need for standardization of functional PAD testing., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The incidence, risk factors, and outcomes associated with Contrast-induced nephropathy (CIN) after Percutaneous Vascular Intervention (PVI) in contemporary medical practice are largely unknown., Methods: A total of 13 126 patients undergoing PVI were included in the analysis. CIN was defined as an increase in serum creatinine from pre-PVI baseline to post-PVI peak Cr of ≥0.5 mg/dL., Results: CIN occurred in 3% (400 patients) of the cohort, and 26 patients (6.5%) required dialysis. Independent predictors of CIN were high and low body weight, diabetes, heart failure, anemia, baseline renal dysfunction, critical limb ischemia, and a higher acuity of the PVI procedure and a contrast dose that was greater than three times the calculated creatinine clearance (CCC) (adjusted OR 1.4, 95% CI: 1.1-1.8, P = 0.003). CIN was strongly associated with adverse outcome including in-hospital death (adjusted OR 18.1, CI 10.7-30.6, P < 0.001), myocardial infarction (adjusted OR 16.2, CI 8.9-29.5, P < 0.001), transient ischemic attack/stroke (adjusted OR 5.5, CI 3.2-14.9, P = 0.001), vascular access complications (adjusted OR 3.4, CI 2.3-5, P < 0.001), and transfusion (adjusted OR 7, CI 5.4-9, P < 0.001). Hospital stay was longer in patients who developed CIN versus those who did not., Conclusions: CIN is not an uncommon complication associated with PVI, can be reliably predicted from pre-procedural variables, including a contrast dose of greater than three times the CCC and is strongly associated with the risk of in-hospital death, MI, stroke, transfusion, and increased hospital length of stay., (© 2017, Wiley Periodicals, Inc.)

Objectives: This study evaluated the safety and effectiveness of self-expanding transcatheter aortic valve replacement (TAVR) in patients with surgical valve failure (SVF)., Background: Self-expanding TAVR is superior to medical therapy for patients with severe native aortic valve stenosis at increased surgical risk., Methods: The CoreValve U.S. Expanded Use Study was a prospective, nonrandomized study that enrolled 233 patients with symptomatic SVF who were deemed unsuitable for reoperation. Patients were treated with self-expanding TAVR and evaluated for 30-day and 1-year outcomes after the procedure. An independent core laboratory was used to evaluate serial echocardiograms for valve hemodynamics and aortic regurgitation., Results: SVF occurred through stenosis (56.4%), regurgitation (22.0%), or a combination (21.6%). A total of 227 patients underwent attempted TAVR and successful TAVR was achieved in 225 (99.1%) patients. Patients were elderly (76.7 ± 10.8 years), had a Society of Thoracic Surgeons Predicted Risk of Mortality score of 9.0 ± 6.7%, and were severely symptomatic (86.8% New York Heart Association functional class III or IV). The all-cause mortality rate was 2.2% at 30 days and 14.6% at 1 year; major stroke rate was 0.4% at 30 days and 1.8% at 1 year. Moderate aortic regurgitation occurred in 3.5% of patients at 30 days and 7.4% of patients at 1 year, with no severe aortic regurgitation. The rate of new permanent pacemaker implantation was 8.1% at 30 days and 11.0% at 1 year. The mean valve gradient was 17.0 ± 8.8 mm Hg at 30 days and 16.6 ± 8.9 mm Hg at 1 year. Factors significantly associated with higher discharge mean aortic gradients were surgical valve size, stenosis as modality of SVF, and presence of surgical valve prosthesis patient mismatch (all p < 0.001)., Conclusions: Self-expanding TAVR in patients with SVF at increased risk for surgery was associated with a low 1-year mortality and major stroke rate, significantly improved aortic valve hemodynamics, and low rates of moderate and no severe residual aortic regurgitation, with improved quality of life., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to evaluate the incidence, risk factors, in-hospital, and long-term outcomes and predictors of mortality of coronary artery perforations (CAP) in the contemporary percutaneous coronary intervention (PCI) era., Background: CAP is a rare but serious complication of PCI associated with increased risk of morbidity and mortality., Methods: We included 181,590 procedures performed across 47 hospitals in Michigan from January 1, 2010 to December 31, 2015. Endpoints evaluated included the incidence of CAP and its association with in-hospital outcomes. Logistic regression analysis was utilized to determine independent risk factors for CAP and to examine whether the effect of CAP on mortality varied by gender., Results: CAP occurred in 625 (0.34%) patients. Independent predictors for CAP included older age, peripheral arterial disease, presence of left ventricular dysfunction or cardiomyopathy, lower body mass index, pre-PCI insertion of a mechanical ventricular support device, treatment of complex lesions (Type C), and treatment of chronic total occlusions, the latter of which was the strongest predictor of perforation (adjusted odds ratio (OR) 7.01, P < 0.001). After adjusting for baseline risk, the incidence of adverse outcomes remained substantially greater in patients with a perforation, with an adjusted OR estimate of 5.00 for mortality (95% CI 3.42-7.31), 3.25 for acute kidney injury (95% CI 2.30-4.58), and 5.26 for transfusion (95% CI 4.03-6.87) (all P < 0.001). Perforation was associated with a higher mortality in women than men (interaction P value = 0.01)., Conclusions: CAP is a rare complication but is associated with high morbidity and mortality especially in women. Further investigation is warranted to determine why women fare worse after CAP. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Biomaterial-based delivery of angiogenic growth factors restores perfusion more effectively than bolus delivery methods in rodent models of peripheral vascular disease, but the same success has not yet been demonstrated in clinically relevant studies of aged or large animals. These studies explore, in clinically relevant models, a therapeutic angiogenesis strategy for the treatment of peripheral vascular disease that overcomes the challenges encountered in previous clinical trials. Alginate hydrogels providing sustained release of vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF) were injected into ischemic hind limbs in middle-aged and old mice, and also in young rabbits, as a test of the scalability of this local growth factor treatment. Spontaneous perfusion recovery diminished with increasing age, and only the combination of VEGF and IGF delivery from gels significantly rescued perfusion in middle-aged (13 months) and old (20 months) mice. In rabbits, the delivery of VEGF alone or in combination with IGF from alginate hydrogels, at a dose 2 orders of magnitude lower than the typical doses used in past rabbit studies, enhanced perfusion recovery when given immediately after surgery, or as a treatment for chronic ischemia. Capillary density measurements and angiographic analysis demonstrated the benefit of gel delivery. These data together suggest that alginate hydrogels providing local delivery of low doses of VEGF and IGF constitute a safe and effective treatment for hind-limb ischemia in clinically relevant animal models, thereby supporting the potential clinical translation of this concept., (© 2017 S. Karger AG, Basel.)

Objective: To determine the predictors of periprocedural blood transfusion and the association of transfusion on outcomes in high risk patients undergoing endoluminal percutaneous vascular interventions (PVI) for peripheral arterial disease., Methods/results: Between 2010-2014 at 47 hospitals participating in a statewide quality registry, 4.2% (n = 985) of 23,273 patients received a periprocedural blood transfusion. Transfusion rates varied from 0 to 15% amongst the hospitals in the registry. Using multiple logistic regression, factors associated with increased transfusion included female gender (OR = 1.9; 95% CI: 1.6-2.1), low creatinine clearance (1.3; 1.1-1.6), pre-procedural anemia (4.7; 3.9-5.7), family history of CAD (1.2; 1.1-1.5), CHF (1.4; 1.2-1.6), COPD (1.2; 1.1-1.4), CVD or TIA (1.2; 1.1-1.4), renal failure CRD (1.5; 1.2-1.9), pre-procedural heparin use (1.8; 1.4-2.3), warfarin use (1.2; 1.0-1.5), critical limb ischemia (1.7; 1.5-2.1), aorta-iliac procedure (1.9; 1.5-2.5), below knee procedure (1.3; 1.1-1.5), urgent procedure (1.7; 1.3-2.2), and emergent procedure (8.3; 5.6-12.4). Using inverse weighted propensity matching to adjust for confounders, transfusion was a significant risk factor for death (15.4; 7.5-31), MI (67; 29-150), TIA/stroke (24; 8-73) and ARF (19; 6.2-57). A focused QI program was associated with a 28% decrease in administration of blood transfusion (p = 0.001) over 4 years., Conclusion: In a large statewide PVI registry, post procedure transfusion was highly correlated with a specific set of clinical risk factors, and with in-hospital major morbidity and mortality. However, using a focused QI program, a significant reduction in transfusion is possible., Competing Interests: The authors have declared that no competing interests exist.

Background: In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery., Objectives: This study sought to determine whether this clinical benefit was sustained over time., Methods: Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure., Results: A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group., Conclusions: Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve(®) System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the use of sarcopenia as a frailty assessment tool for patients with aortic stenosis undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR)., Methods: The study cohort comprised 295 patients who underwent either SAVR (n = 156) or TAVR (n = 139). The mean preoperative Society of Thoracic Surgeons mortality risk score was 4.7%. Preoperative computed tomography (CT) scans were used to calculate gender-standardized total psoas area (TPA), as a validated measure of sarcopenia., Results: For the entire cohort, independent predictors of a composite measure of 30-day death, stroke, renal failure, prolonged ventilation, and deep wound infection included preoperative STS major morbidity and mortality risk score (odds ratio [OR], 91.1; P = .02) and TPA (OR, 0.5; P = .024). Two-year survival was 85.7% in patients with sarcopenia, compared with 93.8% in patients without sarcopenia (P = .02). Independent predictors of late survival included TPA (hazard ratio, 0.47; P = .02). Male sex (OR, 0.52; P = .04) and TPA (OR, 0.6; P = .001) were predictive of high resource utilization. A separate analysis by treatment group found that TPA predicted high resource utilization after SAVR (OR, 0.4; P < .001), but not after TAVR (P = .66)., Conclusions: CT scan-derived measurement of TPA as an objective frailty assessment tool predicts early morbidity and mortality, high resource utilization, and late survival after treatment for aortic stenosis. The correlation observed between sarcopenia and resource utilization after SAVR versus TAVR suggests that this simple and reproducible risk assessment tool also may help identify those patients who will derive optimal benefit from catheter-based therapy., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Unlabelled: Alternative treatment strategies for claudication are needed and cell-based therapies designed to induce angiogenesis are promising. The purpose of this report was to conduct a Phase I safety, dose-escalating, non-randomized, open-label study of autologous, fully differentiated venous endothelial and smooth muscle cells called MultiGeneAngio (MGA) for claudication due to peripheral artery disease. Twelve subjects, at two centers, received a single intra-arterial infusion of a suspension of equal amounts of transduced autologous venous smooth muscle cells expressing vascular endothelial growth factor (VEGF165) and endothelial cells expressing angiopoietin-1 (Ang-1) (Cohort 1: 1 × 10(7), Cohort 2: 2 × 10(7), Cohort 3: 5 × 10(7), Cohort 4: 7 × 10(7)). The treatment was given unblinded and in the more symptomatic lower extremity. Transduced cells were tested for in vitro doubling time, telomerase activity, and gene expression. The main outcomes were clinical safety and tolerability. Other safety measures included ankle-brachial index (ABI) and walking time on a treadmill. All subjects were male (mean age 60 ± 5 years) including 25% with diabetes mellitus. At 1-year follow-up, there was one serious adverse event possibly related to MGA. Safety endpoints including VEGF and Ang-1 plasma protein levels were within normal ranges in all subjects. The mean maximal walking time increased from baseline to 1 year and the index limb ABI was unchanged, indicating no safety concerns. MGA, an autologous, transduced, cell-based therapy was well tolerated and safe in this Phase I study. Further evaluation is warranted in randomized human studies., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT00390767., (© The Author(s) 2015.)

We evaluated the impact of the prescription of evidence-based medical therapy (EBMT) including aspirin (ASA), beta-blockers (BB), ACE-inhibitors or angiotensin receptor blockade (ACE/ARB), and statins prior to discharge after peripheral vascular intervention (PVI) on long-term medication utilization in a large multi-specialty, multicenter quality improvement collaborative. Among patients undergoing coronary revascularization, use of the component medications of EBMT at hospital discharge is a major predictor of long-term utilization. Predictors of EBMT use after PVI are largely unknown. A total of 10,169 patients undergoing PVI between 1 January 2008 and 31 December 2011 were included. Post-PVI discharge and 6-month medication utilization in patients without contra-indications to ASA, BB, ACE/ARB, and statins were compared. ASA was prescribed at discharge to 9345 (92%) patients, BB to 7012 (69%), ACE/ARB to 6424 (63%), and statins to 8342 (82%), and all four component drugs of EBMT in 3953 (39%). Compared with patients not discharged on the appropriate medications, post-procedural use was associated (all p<0.001) with reported 6-month use: ASA (84.5% vs 39.2%), BB (82.5% vs 11.1%), ACE/ARB (78.2% vs 11.8%), statins (84.6% vs 21.8%). Multivariable analysis revealed that prescription of EBMT at the time of discharge remained strongly associated with use at 6 months for each of the individual component drugs as well as for the combination of all four EBMT medications. In conclusion, prescription of the component medications of EBMT at the time of PVI is associated with excellent utilization at 6 months, while failure to prescribe EBMT at discharge is associated with low use of these medications 6 months later. These data suggest that the time of a PVI is a therapeutic window in which to prescribe EBMT in this high-risk cohort and represents an opportunity for quality improvement., (© The Author(s) 2015.)

Although transcatheter aortic valve replacement (TAVR) has expanded the proportion of patients with aortic stenosis (AS) who are candidates for valve replacement, some patients remain untreated, and their outcomes are not clear. We evaluated 172 consecutive patients with severe symptomatic AS referred for TAVR who declined (n = 55) or were not candidates for (n = 117) intervention. We examined clinical and echocardiographic variables associated with mortality. There were 77 deaths, and mean follow-up was 17.9 ± 10.9 months for survivors. Mortality rate at 1 and 2 years was 39.2% and 52.6%, respectively. There was a significant difference in mortality rate between patients who declined the procedure and those who were not candidates (p = 0.001), with 1-year mortality rates of 20.6% and 48.4%, respectively. On multivariate analysis, 4 variables were independently associated with all-cause mortality: New York Heart Association Class IV heart failure (hazard ratio [HR] 2.6, 95% confidence interval [CI] 1.6 to 4.2, p <0.001), glomerular filtration rate <48 ml/min (HR 2.1, 95% CI 1.3 to 3.4, p = 0.002), albumin <3.9 g/dl (HR 1.9, 95% CI 1.2 to 3.1, p = 0.007), and ejection fraction <50% (HR 1.9, 95% CI 1.4 to 3.0, p = 0.01). In this new era with expanded treatment options, patients with severe symptomatic AS who remain untreated after referral for TAVR experience a mortality rate of 39% at 1 year. The presence of advanced heart failure, renal dysfunction, low albumin, and/or left ventricular dysfunction identifies patients at higher risk of mortality., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: Blood transfusions are common among patients undergoing major vascular surgery. Prior studies suggest an association between blood transfusion and increased morbidity and mortality among patients undergoing cardiac surgery. The predictors of perioperative transfusion and its impact on patients undergoing vascular surgery have been poorly defined., Methods: We examined data from a large multicenter quality improvement vascular surgical registry of all patients undergoing elective or urgent open peripheral arterial disease procedures, endovascular aneurysm repair, or open abdominal aortic aneurysm (AAA) repair between January 2012 and December 2013. Emergency cases, carotid endarterectomy, and carotid artery stenting were excluded. Univariate and multivariate logistic regression modeling was used to identify predictors of transfusion and association of transfusion with outcomes. All regression models had Hosmer-Lemeshow P > .05 and area under the receiver operating characteristic curve of >0.8, confirming excellent goodness of fit and discrimination., Results: Our study population comprised 2946 patients who underwent open peripheral arterial disease procedures (n = 1744), open AAA repair (n = 175), or endovascular aneurysm repair (n = 1027) at 22 hospitals. The overall transfusion rate was 25%, at a median nadir hemoglobin level of 7.7 g/dL. Independent factors predicting transfusion included female gender (odds ratio [OR], 2.6; 95% confidence interval [CI], 2.1-3.2), nonwhite race (OR, 2.7; 95% CI, 1.4-5.2), preoperative admission status (ie, acute care hospital) (OR, 2.6; 95% CI, 1.3-5.3), preoperative anemia (OR, 4.2; 95% CI, 3.3-5.1), congestive heart failure (OR, 1.4; 95% CI, 1.1-1.9), prior myocardial infarction (OR, 1.3; 95% CI, 1.01-1.6), clopidogrel (OR, 1.4; 95% CI, 1.2-1.8), open AAA repair (OR, 25; 95% CI, 17-39), open bypass (OR, 3.5; 95% CI, 2.7-4.6), and urgent procedures (OR, 1.4; 95% CI, 1.1-1.8). With adjustment for major covariates, perioperative transfusion was independently associated with death (OR, 6.9; 95% CI, 3.2-15), myocardial infarction (OR, 8; 95% CI, 3.7-17), and pneumonia (OR, 7.4; 95% CI, 3.3-17)., Conclusions: Perioperative transfusion in vascular surgical patients is independently associated with increased 30-day morbidity and mortality. Given indeterminate causation, these data suggest the need for a prospective transfusion threshold study in vascular surgical patients., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Given the very ill nature of patients with critical limb ischemia (CLI), the use of percutaneous vascular interventions (PVIs) for limb salvage may or may not be efficacious; in particular, for those with polyvascular arterial disease. Herein, we reviewed large, multi-institutional outcomes of PVI in polyvascular and peripheral arterial disease (PAD) patients with CLI. An 18-hospital consortium collected prospective data on patients undergoing endovascular interventions for PAD with 6-month follow-up from January 2008 to December 2011. The patient cohort included 4459 patients with CLI; of those, 3141 patients had polyvascular (coronary artery disease, cerebrovascular disease and PAD) disease, whereas 1318 patients suffered from only PAD. All patients were elderly and with significant comorbidities. The mean ankle-brachial index (ABI) was 0.44 and was not different between those with and without polyvascular disease. Polyvascular patients had more femoropopliteal and infra-inguinal interventions and less aortoiliac interventions than PAD patients. Pre- and post-procedural cardioprotective medication use was less in the PAD patients as compared with polyvascular patients. Vascular complications requiring surgery were higher in PAD patients whereas other access complications were similar between groups. At 6-month follow-up, death was more common in the polyvascular group (6.7% vs 4.1%, p<0.001) as was repeat PVI, but no difference was found in the amputation rate. Considering the group as a whole at the 6-month follow-up, predictors of amputation/death included age (HR=1.01; 95% CI=1.002-1.02), anemia (HR=2.6; 95% CI=2.1-3.2), diabetes mellitus (HR=1.6; 95% CI=1.3-1.9), congestive heart failure (HR=1.6; 95% CI=1.4-1.9), and end-stage renal failure (HR=1.9; 95% CI=1.5-2.3), while female sex was protective (HR=0.7; 95% CI=0.6-0.8). In conclusion, from examination of this large, multicenter, multi-specialist practice registry, patients with polyvascular disease had higher 6-month mortality than PAD patients, but this was not a factor in 6-month limb amputation outcomes. This study also underscores that PAD patients still lag in cardioprotective medication use as compared with polyvascular patients., (© The Author(s) 2014.)

Objectives: This study sought to examine sex-related differences in outcomes related to peripheral vascular intervention (PVI) procedures., Background: Percutaneous PVI is frequently performed for the treatment of peripheral arterial disease (PAD). However, little is known about sex-related differences related to PVI procedures., Methods: We assessed the impact of sex among 12,379 patients (41% female) who underwent lower extremity (LE)-PVI from 2004 to 2009 at 16 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PVI registry. Multivariate propensity-matched analyses were performed to adjust for differences in baseline characteristics, procedural indications, and comorbidities on the basis of sex., Results: Compared with men, women were older and have multilevel disease and critical limb ischemia. In a propensity-matched analysis, female sex was associated with a higher rate of vascular complications, transfusions, and embolism. No differences were observed for in-hospital death, myocardial infarction, or stroke or transient ischemic attack. Technical success was more commonly achieved in women (91.2% vs. 89.1%, p = 0.014), but because of a higher complication rate, the overall procedural success rates were similar in men and women (79.7% vs. 81.6%, p = 0.08)., Conclusions: Women represent a significant proportion of patients undergoing LE-PVI, have a more severe and complex disease process, and are at increased risk for adverse outcomes. Despite higher complications rates, women had similar procedural success compared with men, making PVI an effective treatment strategy among women with LE-PAD., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Percutaneous coronary intervention (PCI) for stable coronary artery disease (CAD) is not superior to optimal medical therapy. It remains unclear if patients who receive PCI for stable CAD are receiving appropriate medical therapy., Methods: We evaluated the medical management of 60,386 patients who underwent PCI for stable CAD between 2004 and 2009. We excluded patients with contraindications to aspirin, clopidogrel, statins, or β-blockers (BBs). We defined essential medical therapy of stable CAD as treatment with aspirin, statin, and BB before PCI and treatment with aspirin, clopidogrel, and statin after PCI., Results: Essential medical therapy was used in 53.0% of patients before PCI and 82.1% at discharge. Aspirin was used in 94.8% patients before PCI and 98.3% of after PCI. Statins were used in 69.5% of patients before PCI and 84.5% after PCI. β-Blockers were used in 72.8% of patients before PCI. Clopidogrel was used in 97.3% of patients after PCI. Patients with a history of myocardial infarction or revascularization before PCI had better medical therapy compared with patients without such a history (62.8% vs 34.3% [P < .001] before PCI and 83.6% vs 79.1% [P < .001] after PCI). After adjusting for confounders and clustering, women (odds ratio 0.74, 95% CI 0.71-0.78) and patients on dialysis (odds ratio 0.68, 95% CI 0.57-0.80) were less likely to receive a statin at discharge., Conclusions: Medical therapy remains underused before and after PCI for stable CAD. Women are less likely to receive statin therapy. There are significant opportunities to optimize medical therapy in patients with stable CAD., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Background: Peripheral arterial disease is a manifestation of systemic atherosclerosis and is predictive of future cardiovascular events. Clinical trial data have demonstrated that medical therapy can attenuate cardiovascular morbidity and mortality in patients with peripheral arterial disease. The utilization and impact of recommended medical therapy in a contemporary population of patients who undergo percutaneous interventions for lifestyle-limiting peripheral arterial disease is unknown., Methods and Results: Using the Blue Cross Blue Shield of Michigan Cardiovascular Consortium Peripheral Vascular Intervention (BMC2 PVI) database, we identified 1357 peripheral vascular intervention encounters between January 2007 and December 2009 for the purpose of treating claudication. Before the intervention, 85% of these patients used aspirin, 76% used statin, 65% abstained from smoking, and 47% did all 3. There was no difference in cardiovascular events among those taking an aspirin and a statin on admission and those who were not. However, in both an unadjusted and a multivariable analysis, the odds of an adverse peripheral vascular outcome (repeat peripheral intervention, amputation, or limb salvage surgery) within 6 months decreased by more than half in patients receiving aspirin and statin therapy before peripheral vascular intervention as compared with those who received neither (odds ratio, 0.45; 95% CI, 0.29-0.71)., Conclusions: The fundamental elements of medical therapy in patients with lifestyle-limiting claudication are often underutilized before referral for revascularization. Appropriate medical therapy before percutaneous revascularization is associated with fewer peripheral vascular events at 6 months.

Background: The traditional definition of contrast-induced nephropathy (CIN) has been an absolute rise of serum creatinine (Cr) of ≥0.5 mg/dL, although most recent clinical trials have included a ≥25% increase from baseline Cr. The clinical implication of this definition change remains unknown., Methods and Results: We compared the association of the two definitions with risk of death or need for dialysis among 58,957 patients undergoing percutaneous coronary intervention in 2007 to 2008 in a large collaborative registry. Patients with a preexisting history of renal failure requiring dialysis were excluded. Contrast-induced nephropathy as defined by a rise in Cr ≥0.5 mg/dL (CIN(Traditional)) developed in 1,601, whereas CIN defined either as Cr ≥0.5 mg/dL or ≥25% increase in baseline Cr (CIN(New)) developed in 4,308 patients. Patients meeting the definition of CIN(New) but not CIN(Traditional) were classified as CIN(Incremental) (n = 2,707). Compared with CIN(New), CIN(Traditional) was more commonly seen in patients with abnormal renal function, which was more likely to develop in patients with normal renal function at baseline. Compared with CIN(Incremental), patients meeting the definition of CIN(Traditional) were more likely to die (16.7% vs 1.7%) and require in-hospital dialysis (9.8% vs 0%)., Conclusions: Our data suggest that the traditional definition of CIN (a rise in Cr of ≥0.5 mg/dL) in patients undergoing PCI is superior to ≥25% increase in Cr at identifying patients at greater risk for adverse renal and cardiac events., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Objectives: This study sought to evaluate the effect of age on procedure type, periprocedural management, and in-hospital outcomes of patients undergoing lower-extremity (LE) peripheral vascular intervention (PVI)., Background: Surgical therapy of peripheral arterial disease is associated with significant morbidity and mortality in the elderly. There are limited data related to the influence of advanced age on the outcome of patients undergoing percutaneous LE PVI., Methods: Clinical presentation, comorbidities, and in-hospital outcomes of patients undergoing LE PVI in a multicenter, multidisciplinary registry were compared between 3 age groups: < 70 years, between 70 and 80 years, and ≥ 80 years (elderly group)., Results: In our cohort, 7,769 patients underwent LE PVI. The elderly patients were more likely to be female and to have a greater burden of comorbidities. Procedural success was lower in the elderly group (74.2% for age ≥ 80 years vs. 78% for age 70 to < 80 years and 81.4% in patients age < 70 years, respectively; p < 0.0001). Unadjusted rates of procedure-related vascular access complications, post-procedure transfusion, contrast-induced nephropathy, amputation, and major adverse cardiac events were higher in elderly patients. After adjustment for baseline covariates, the elderly patients were more likely to experience vascular access complications; however, advanced age was not found to be associated with major adverse cardiac events, transfusion, contrast-induced nephropathy, or amputation., Conclusions: Contemporary PVI can be performed in elderly patients with high procedural and technical success with low rates of periprocedural complications including mortality. These findings may support the notion of using PVI as a preferred revascularization strategy in the treatment of severe peripheral arterial disease in the elderly population., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Hypothesis: The antegrade access (AA) for percutaneous arterial interventions is associated with a higher complication rate than is the retrograde access (RA)., Design: Retrospective case review., Setting: A statewide consortium for peripheral vascular interventions consisting of 13 Michigan hospitals collecting data on their endovascular procedures., Patients: Demographic and procedure data on all patients receiving a percutaneous peripheral arterial intervention were entered prospectively by a full-time clinical nurse specialist in each hospital site., Main Outcome Measures: We evaluated vascular complications as a composite of retroperitoneal hematoma, pseudoaneurysm, hematoma requiring blood transfusion, arteriovenous fistula, acute thrombosis, or the need for surgical repair of the access site., Results: In a 2-year period, we collected 6343 cases, of which 5918 had complete data regarding arterial access; of these, 745 (12.6%) were performed via an AA. There were fewer women and smokers (P < .001) in the AA group but more diabetic patients (P < .001). The indications for intervention were more frequently rest pain (P < .001) and limb salvage (P < .001) in the AA group. Multivariate regression analysis showed that the odds of complications were significantly higher with a larger sheath (95% confidence interval, 1.53-4.06; P < .001). Also, the incidence of blood transfusion and subsequent amputation was significantly higher in the AA group (P < .001)., Conclusion: Endovascular procedures performed via an AA are more likely to result in perioperative complications and therefore should be used cautiously.

Background: historically, women with ST elevation myocardial infarction (STEMI) have had a higher mortality compared with men. It is unclear if these differences persist among patients undergoing contemporary primary percutaneous coronary intervention (PCI) with focus on early reperfusion., Methods: we assessed the impact of sex on the outcome of 8,771 patients with acute STEMI who underwent primary PCI from 2003 to 2008 at 32 hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry. A propensity-matched analysis was performed to adjust for differences in baseline characteristics and comorbidities between men and women., Results: twenty-nine percent of the cohort was female. Compared with men, women were older and had more comorbidity. Female sex was associated with a higher unadjusted in-hospital mortality (6.02% vs 3.45%, odds ratio [OR] 1.79, 95% CI 1.45-2.22, P < .0001) and higher risk of contrast-induced nephropathy (OR 1.75, P < .0001), vascular complications (OR 2.13, P < .0001), and postprocedure transfusion (OR 2.84, P < .0001). The gap in sex-specific mortality narrowed over time. In a propensity-matched analysis, female sex was associated with a higher rate of transfusion (OR 1.88, 95% CI 1.57-2.24, P < .0001) and vascular complications (OR 1.65, 95% CI 1.26-2.14, P < .0002); but there was no difference in mortality (OR 1.30, 95% CI 0.98-1.72, P = .07)., Conclusions: women make up approximately one third of patients undergoing primary PCI for STEMI. Female sex is associated with an apparent hazard of increased mortality among patients undergoing primary PCI for STEMI, but this difference is likely explained by older age and worse baseline comorbidities among women.

Background: The optimal degree of heparin anticoagulation for peripheral vascular interventions (PVIs) has not been defined. We sought to correlate total heparin dose and peak procedural activated clotting time (ACT) with postprocedural outcomes in patients undergoing PVI., Methods and Results: We studied 4743 patients who received heparin during PVIs in a regional, multicenter registry. From those, 1246 had recorded peak procedural ACT with the same point-of-care device. Periprocedural and in-hospital outcomes were compared between patients who received a total heparin dose <60 U/kg (n=2161) and ≥60 U/kg (n=2582). Similarly, outcomes were evaluated between groups with a peak procedural ACT <250 seconds (n=855) and ≥250 seconds (n=391). Technical and procedural success as well as intraprocedural thrombotic events did not differ between groups. Patients with heparin dose ≥60 U/kg had a higher rate of postprocedural hemoglobin drop ≥3 g/dL (7.09% versus 5.09%, respectively, P=0.004) and a higher transfusion rate compared with those with heparin dose <60 U/kg (4.92% versus 3.15%, respectively, P=0.002). In multivariate analysis, independent predictors of bleeding requiring transfusion were total heparin dose ≥60 U/kg, ACT ≥250 seconds, female sex, age ≥70 years, prior anemia, prior heart failure, low creatinine clearance, hybrid vascular surgery, rest pain, and below-knee intervention. In propensity-matched, risk-adjusted models and after hierarchical modeling, total heparin dose ≥60 U/kg and ACT ≥250 seconds remained strong predictors of post-PVI drop in hemoglobin ≥3 g/dL or transfusion., Conclusions: During PVI, higher total heparin dose (≥60 U/kg) and peak ACT ≥250 seconds were predictors of postprocedural transfusion. The high technical and procedural success in all groups suggests that use of weight-based heparin dosing with a target ACT <250 seconds in PVI may minimize the bleeding risk without compromising procedural success or increasing thromboembolic complications.

Background: Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI) in patients with acute ST elevation myocardial infarction (STEMI) have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI., Methods: Seventeen randomized trials (n = 3,909 patients) of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) grade flow, and post procedural ST segment resolution (STR) using random-effects and fixed-effects models., Results: There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42) among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007), MBG 3 (730/1526 vs. 486/1513, OR 2.42, P < 0.001), STR (923/1500 vs. 715/1494, OR 2.30, P < 0.001), and with a higher risk of stroke (14/1403 vs. 3/1413, OR 2.88, 95% CI 1.06-7.85, P = 0.04). Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (21/949 vs.36/953, OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (20/416 vs.10/418, OR 2.07, 95% CI 0.95-4.48, P = 0.07)., Conclusions: Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices.

Purpose: The aim was to investigate that a bio-degradable alginate and poly lactide-co-glycolide (PLG) system capable of delivering growth factors sequentially would be superior to single growth factor delivery in promoting neovascularization and improving perfusion., Methods: Three groups of apoE null mice underwent unilateral hindlimb ischemia surgery and received ischemic limb intramuscular injections of alginate (Blank), alginate containing VEGF(165) (VEGF), or alginate containing VEGF(165) combined with PLG microspheres containing PDGF-BB (VEGF/PDGF). Vascularity in the ischemic hindlimb was assessed by morphologic and immunohistochemical end-points, while changes in blood flow were assessed by Laser Doppler Perfusion Index. Muscle VEGF and PDGF content was assessed at multiple time points., Results: In the VEGF/PDGF group, local tissue VEGF and PDGF levels peaked at week 2 and 4, respectively, with detectable PDGF levels at week 6. At week 6, mean vessel mean diameter was significantly greater in the VEGF/PDGF group compared to the VEGF or Blank groups with evidence of well-formed smooth muscle-lined arterioles., Conclusions: Sequential delivery of VEGF and PDGF using an injectable, biodegradable platform resulted in stable and sustained improvements in perfusion. This sustained, control-released, injectable alginate polymer system is a promising approach for multiple growth factor delivery in clinical application.

Objectives: We evaluated the association between guiding catheter size and complications of percutaneous coronary intervention (PCI)., Background: The association between guiding catheter size and complications of PCI in contemporary practice remains controversial., Methods: Procedure and outcome variables from 103,070 consecutive patients that underwent PCI with 6-F (n = 64,335), 7-F (n = 32,676), and 8-F (n = 6,059) guide catheters were compared., Results: Compared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with incrementally more contrast agent use, and more post-PCI complications including contrast-induced nephropathy, vascular access site complications, bleeding, transfusion, major adverse cardiac event, and death. After multivariate analysis, the use of larger guides were associated with a higher risk of contrast-induced nephropathy (7-F odds ratio [OR]: 1.18, p = 0.0004; 8-F OR: 1.44, p < 0.0001), vascular complications (7-F OR: 1.19, p = 0.0002, 8-F OR: 1.68, p < 0.0001), decline in hemoglobin >3 g/dl (7-F OR: 1.12, p < 0.0001, 8-F OR: 1.72, p < 0.0001), and post-procedure blood transfusion (7-F OR: 1.08, p = 0.03; 8-F OR: 1.80, p < 0.0001), whereas major adverse cardiac events (7-F OR: 1.06, p = 0.13; 8-F OR: 1.37, p < 0.0001) and in-hospital mortality (7-F OR: 1.11, p = 0.13; 8-F OR: 1.34, p = 0.03) were increased with 8-F but not 7-F guides., Conclusions: Compared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with more contrast medium use, renal complications, bleeding, vascular access site complications, greater need for post-procedure transfusion, and 8-F guides with increased nephropathy requiring dialysis, in-hospital major adverse cardiac events, and mortality. These data suggest that selection of smaller guide catheters may result in improved clinical outcome in patients undergoing contemporary PCI.

Background: Current guidelines recommend abciximab as the preferred agent for patients undergoing primary percutaneous coronary intervention, yet small-molecule glycoprotein IIb/IIIa inhibitors are more commonly used in clinical practice. The objective of our meta-analysis was to evaluate for differences in clinical outcome between small-molecule glycoprotein IIb/IIIa inhibitors and abciximab in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention., Methods and Results: Five randomized trials (n=2138 patients) comparing tirofiban or eptifibatide with abciximab as an adjunctive therapy to primary percutaneous coronary intervention were included in this meta-analysis. Summary odds ratios (ORs) for 30-day death, reinfarction, and major bleeding were calculated using random- and fixed-effect models. There were no differences in 30-day mortality (1.9% for small molecule versus 2.3% for abciximab; OR, 0.84; 95% CI, 0.46 to 1.55; P=0.58), reinfarction (1.3% versus 1.2%; OR, 1.22; 95% CI, 0.51 to 2.91; P=0.69), or major bleeding (1.7% versus 1.3%; OR, 1.21; 95% CI, 0.58 to 2.49; P=0.61) between the 2 adjunctive strategies. Similarly, there was no significant difference in the incidence of death (3.9% versus 5%; OR, 0.77; 95% CI, 0.41 to 1.46; P=0.43) or reinfarction on follow-up at 8 months between small-molecule glycoprotein IIb/IIIa inhibitors and abciximab., Conclusions: In patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction, no difference in outcome could be identified in patients treated with small-molecule glycoprotein IIb/IIIa inhibitor or abciximab.