bluuebunny/crossref_metadata_2025_split huggingface dataset:
Failure to Treat Life-Threatening Ventricular Tachyarrhythmias in Contemporary Implantable Cardioverter–Defibrillators
Authors: Thøgersen Anna Margrethe , Larsen Jacob Moesgaard , Johansen Jens Brock , Abedin Moeen , Swerdlow Charles D. 
Published: September 2017

Background:
In clinical trials, manufacturer-specific, strategic programming of implantable cardioverter–defibrillators (ICDs), including faster detection rates, reduces unnecessary therapy but permits therapy for ventricular tachycardia/ventricular fibrillation (VF). Present consensus recommends a generic rate threshold between 185 and 200 beats per minute, which exceeds the rate tested in clinical trials for some manufacturers. In a case series, we sought to determine the relationship between programmed parameters and failure of modern ICDs to treat VF.

Methods and Results:
We reviewed cases in which normally functioning ICDs failed to deliver timely therapy for VF from April 2015 to January 2017 at 4 institutions. Of 10 ambulatory patients, 5 died from untreated VF, 4 had cardiac arrests requiring external shocks, and 1 was rescued by a delayed ICD shock. VF did not satisfy programmed detection criteria in 9 patients (90%). Seven of these patients had slowest detection rates that were consistent with generic recommendations but not tested in a peer-reviewed trial for their manufacturer’s ICDs. Manufacturer-specific factors interacted with fast detection rates to withhold therapy, including strict VF episode termination rules, enhancements to minimize T-wave oversensing, and features that restrict therapy to regular rhythms in ventricular tachycardia zones. Untreated VF despite recommended programming accounted for 56% of sudden deaths and 11% of all deaths during the study period.

Conclusions:
Complex and unanticipated interactions between manufacturer-specific features and generic programming can prevent therapy for VF. More data are needed to assess the risks and benefits of translating evidence-based detection parameters from one manufacturer to another.
Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency
Authors: Zeller Thomas , Langhoff Ralf , Rocha-Singh Krishna J. , Jaff Michael R. , Blessing Erwin , Amann-Vesti Beatrice , Krzanowski Marek , Peeters Patrick , Scheinert Dierk , Torsello Giovanni , Sixt Sebastian , Tepe Gunnar 
Published: September 2017

Background—
Studies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB.

Methods and Results—

DEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency—A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (
P
=0.05). Predilation rate was 16.7% for DA+DCB versus 74.1% for DCB; postdilation rate was 6.3% for DA+DCB versus 33.3% for DCB. Technical success was superior for DA+DCB (89.6% versus 64.2%;
P
=0.004). Overall bail-out stenting rate was 3.7%, and rate of flow-limiting dissections was 19% for DCB and 2% for DA+DCB (
P
=0.01). One-year primary outcome of angiographic percent diameter stenosis was 33.6±17.7% for DA+DCB versus 36.4±17.6% for DCB (
P
=0.48), and clinically driven target lesion revascularization was 7.3% for DA+DCB and 8.0% for DCB (
P
=0.90). Duplex ultrasound patency was 84.6% for DA+DCB, 81.3% for DCB (
P
=0.78), and 68.8% for calcified lesions. Freedom from major adverse events at 1 year was 89.3% for DA+DCB and 90.0% for DCB (
P
=0.86).

Conclusions—
DA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted.

Clinical Trial Registration—

http://www.clinicaltrials.gov
. Unique Identifier: NCT01366482.
White Blood Cell Count and Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention in the Contemporary Era
Authors: Shah Binita , Baber Usman , Pocock Stuart J. , Krucoff Mitchell W. , Ariti Cono , Gibson C. Michael , Steg Philippe Gabriel , Weisz Giora , Witzenbichler Bernhard , Henry Timothy D. , Kini Annapoorna S. , Stuckey Thomas , Cohen David J. , Iakovou Ioannis , Dangas George , Aquino Melissa B. , Sartori Samantha , Chieffo Alaide , Moliterno David J. , Colombo Antonio , Mehran Roxana 
Published: September 2017

Background—
Elevated white blood cell (WBC) count is associated with increased major adverse cardiovascular events (MACE) in the setting of acute coronary syndrome. The aim of this study was to evaluate whether similar associations persist in an all-comers population of patients undergoing percutaneous coronary intervention in the contemporary era.

Methods and Results—

In the multicenter, prospective, observational PARIS study (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients Registry), 4222 patients who underwent percutaneous coronary intervention in the United States and Europe between July 1, 2009, and December 2, 2010, were evaluated. The associations between baseline WBC and MACE (composite of cardiac death, stent thrombosis, spontaneous myocardial infarction, or target lesion revascularization) at 24-month follow-up were analyzed using multivariable Cox regression. Patients with higher WBC were more often younger, smokers, and with less comorbid risk factors compared with those with lower WBC. After adjustment for baseline and procedural characteristics, WBC remained independently associated with MACE (hazard ratio [HR] per 10
3
cells/μL increase, 1.05 [95% confidence intervals (CI), 1.02–1.09];
P
=0.001), cardiac death (HR, 1.10 [95% CI, 1.05–1.17];
P
<0.001), and clinically indicated target revascularization (HR, 1.04 [95% CI, 1.00–1.09];
P
=0.03) but not stent thrombosis (HR, 1.07 [95% CI, 0.99–1.16];
P
=0.10) or spontaneous myocardial infarction (HR, 1.03 [95% CI, 0.97–1.09];
P
=0.29). The association between WBC and MACE was consistent in acute coronary syndrome and non–acute coronary syndrome presentations (interaction
P
=0.15).

Conclusions—
Increased WBC is an independent predictor of MACE after percutaneous coronary intervention in a contemporary all-comers cohort. Further studies to delineate the underlying pathophysiologic role of elevated WBC across a spectrum of coronary artery disease presentations are warranted.

Clinical Trial Registration—

URL:
http://www.clinicaltrials.gov
. Unique identifier: NCT00998127.
Gait Speed Can Predict Advanced Clinical Outcomes in Patients Who Undergo Transcatheter Aortic Valve Replacement
Authors: Kano Seiji , Yamamoto Masanori , Shimura Tetsuro , Kagase Ai , Tsuzuki Masanao , Kodama Atsuko , Koyama Yutaka , Kobayashi Toshihiro , Shibata Kenichi , Tada Norio , Naganuma Toru , Araki Motoharu , Yamanaka Futoshi , Shirai Shinichi , Mizutani Kazuki , Tabata Minoru , Ueno Hiroshi , Takagi Kensuke , Higashimori Akihiro , Otsuka Toshiaki , Watanabe Yusuke , Hayashida Kentaro 
Published: September 2017

Background—
Gait speed reflects an important factor of frailty and is associated with an increased risk of late mortality in patients with cardiac disease. This study sought to assess the prognostic value of gait speed in elderly patients who underwent transcatheter aortic valve replacement.

Methods and Results—

We investigated the 5-m or 15-feet gait speed (m/sec) in 1256 patients who underwent transcatheter aortic valve implantation using data from the OCEAN-TAVI Japanese multicenter registry (Optimized Catheter Valvular Intervention–Transcatheter Aortic Valve Implantation). Baseline characteristics, procedural outcomes, and all-cause mortality were compared among groups defined by differential gait speed classification: model 1, normal (>0.83 m/sec; n=563; 44.8%), slow (0.5–0.83 m/sec; n=429; 34.2%), slowest (<0.83 m/sec; n=205; 16.3%), unable to walk (n=48; 3.8%); and model 2, classification and regression tree survival model indicating the threshold of gait speed as 0.385 m/sec (>0.385 m/sec; n=1080 versus ≤0.385 m/sec; n=117). The cumulative 1-year mortality rate showed significant differences in the classical gait speed groups in model 1 (7.6%, 6.6%, 18.2%, and 40.7%, respectively;
P
<0.001) and survival classification and regression tree group in model 2 (7.7% versus 21.9%;
P
<0.001). The slowest walkers and those unable to walk demonstrated independent associations with increased midterm mortality after adjustment for several confounding factors (hazard ratio, 1.83, 4.28; 95% confidence interval, 1.03–3.26, 2.22–8.72;
P
=0.039, <0.001, respectively). Gait speed <0.385 m/sec determined by classification and regression tree also independently associated with worse prognosis (hazard ratio, 2.40; 95% confidence interval, 1.75–5.88;
P
=0.001).

Conclusions—
Gait speed using both traditional and specific classification is useful as a potential marker for predicting vulnerable patients associated with adverse clinical outcomes after transcatheter aortic valve replacement.
Phase 2a Clinical Trial of Mitochondrial Protection (Elamipretide) During Stent Revascularization in Patients With Atherosclerotic Renal Artery Stenosis
Authors: Saad Ahmed , Herrmann Sandra M.S. , Eirin Alfonso , Ferguson Christopher M. , Glockner James F. , Bjarnason Haraldur , McKusick Michael A. , Misra Sanjay , Lerman Lilach O. , Textor Stephen C. 
Published: September 2017

Background—
Atherosclerotic renal artery stenosis reduces renal blood flow (RBF) and amplifies stenotic kidney hypoxia. Revascularization with percutaneous transluminal renal angioplasty (PTRA) and stenting often fails to recover renal function, possibly because of ischemia/reperfusion injury developing after PTRA. Elamipretide is a mitochondrial-targeted peptide that binds to cardiolipin and stabilizes mitochondrial function. We tested the hypothesis that elamipretide plus PTRA would improve renal function, oxygenation, and RBF in patients with atherosclerotic renal artery stenosis undergoing PTRA.

Methods and Results—

Inpatient studies were performed in patients with severe atherosclerotic renal artery stenosis scheduled for PTRA. Patients were treated before and during PTRA with elamipretide (0.05 mg/kg per hour intravenous infusion, n=6) or placebo (n=8). Stenotic kidney cortical/medullary perfusion and RBF were measured using contrast-enhanced multidetector CT, and renal oxygenation by 3-T blood oxygen level−dependent magnetic resonance imaging before and 3 months after PTRA. Age and basal glomerular filtration rate did not differ between groups. Blood oxygen level−dependent imaging demonstrated increased fractional hypoxia 24 hours after angiography and stenting in placebo (+47%) versus elamipretide (−6%). These were reverted to baseline 3 months later. Stenotic kidney RBF rose (202±29–262±115 mL/min;
P
=0.04) 3 months after PTRA in the elamipretide-treated group only. Over 3 months, systolic blood pressure decreased, and estimated glomerular filtration rate increased (
P
=0.003) more in the elamipretide group than in the placebo group (
P
=0.11).

Conclusions—
Adjunctive elamipretide during PTRA was associated with attenuated postprocedural hypoxia, increased RBF, and improved kidney function in this pilot trial. These data support a role for targeted mitochondrial protection to minimize procedure-associated ischemic injury and to improve outcomes of revascularization for human atherosclerotic renal artery stenosis.

Clinical Trial Registration—

URL:
https://www.clinicaltrials.gov
. Unique identifier: NCT01755858.
Coronary Perforation Complicating Percutaneous Coronary Intervention in Patients With a History of Coronary Artery Bypass Surgery
Authors: Kinnaird Tim , Anderson Richard , Ossei-Gerning Nick , Cockburn James , Sirker Alex , Ludman Peter , de Belder Mark , Johnson Thomas W. , Copt Samuel , Zaman Azfar , Mamas Mamas A. 
Published: September 2017

Background—
The evidence base for coronary perforation (CP) occurring during percutaneous coronary intervention in patients with a history of coronary artery bypass surgery (PCI-CABG) is limited and the long-term effects unclear. Using a national PCI database, the incidence, predictors, and outcomes of CP during PCI-CABG were defined.

Methods and Results—

Data were analyzed on all PCI-CABG procedures performed in England and Wales between 2005 and 2013. Multivariate logistic regressions and propensity scores were used to identify predictors of CP and its association with outcomes. During the study period, 309 CPs were recorded during 59 644 PCI-CABG procedures with the incidence rising from 0.32% in 2005 to 0.68% in 2013 (
P
<0.001 for trend). Independent associates of perforation in native vessels included age, chronic occlusive disease intervention, rotational atherectomy use, number of stents, hypertension, and female sex. In graft PCI, predictors of perforation were history of stroke, New York Heart Association class, and number of stents used. In-hospital clinical complications including Q-wave myocardial infarction (2.9% versus 0.2%;
P
<0.001), major bleeding (14.0% versus 0.9%;
P
<0.001), blood transfusion (3.7% versus 0.2%;
P
<0.001), and death (10.0% versus 1.1%;
P
<0.001) were more frequent in patients with CP. A continued excess mortality occurred after perforation, with an odds ratio for 12-month mortality of 1.35 for perforation survivors compared with matched nonperforation survivors without a CP (
P
<0.0001).

Conclusions—
CP is an infrequent event during PCI-CABG but is closely associated with adverse clinical outcomes. A legacy effect of perforation on 12-month mortality was observed.
Clinical Profile and Consequences of Atrial Fibrillation in Hypertrophic Cardiomyopathy
Authors: Rowin Ethan J. , Hausvater Anais , Link Mark S. , Abt Patrick , Gionfriddo William , Wang Wendy , Rastegar Hassan , Estes N. A. Mark , Maron Martin S. , Maron Barry J. 
Published: September 2017

Background:
Atrial fibrillation (AF), the most common sustained arrhythmia in hypertrophic cardiomyopathy (HCM), is capable of producing symptoms that impact quality of life and is associated with risk for embolic stroke. However, the influence of AF on clinical course and outcome in HCM remains incompletely resolved.

Methods:
Records of 1558 consecutive patients followed at the Tufts Medical Center Hypertrophic Cardiomyopathy Institute for 4.8±3.4 years (from 2004 to 2014) were accessed.

Results:

Of the 1558 patients with HCM, 304 (20%) had episodes of AF, of which 226 (74%) were confined to symptomatic paroxysmal AF (average, 5±5; range, 1 to >20), whereas 78 (26%) developed permanent AF, preceded by 7±6 paroxysmal AF episodes. At last evaluation, 277 patients (91%) are alive at 62±13 years of age, including 89% in New York Heart Association class I or II. No difference was found in outcome measures for patients with AF and age- and sex-matched patients with HCM without AF. Four percent of patients with AF died of HCM-related causes (n=11), with annual mortality 0.7%; mortality directly attributable to AF (thromboembolism without prophylactic anticoagulation) was 0.1% per year (n=2 patients). Patients were treated with antiarrhythmic drugs (most commonly amiodarone [n=103] or sotalol [n=78]) and AF catheter ablation (n=49) or the Maze procedure at surgical myectomy (n=72). Freedom from AF recurrence at 1 year was 44% for ablation patients and 75% with the Maze procedure (
P
<0.001). Embolic events were less common with anticoagulation prophylaxis (4/233, 2%) than without (9/66, 14%) (
P
<0.001).

Conclusions:
Transient symptomatic episodes of AF, often responsible for impaired quality of life, are unpredictable in frequency and timing, but amenable to effective contemporary treatments, and infrequently progress to permanent AF. AF is not a major contributor to heart failure morbidity or a cause of arrhythmic sudden death; when treated, it is associated with low disease-related mortality, no different than for patients without AF. AF is an uncommon primary cause of death in HCM virtually limited to embolic stroke, supporting a low threshold for initiating anticoagulation therapy.
Radiographic and Clinical Brain Infarcts in Cardiac and Diagnostic Procedures
Authors: Cho Sung-Min , Deshpande Abhishek , Pasupuleti Vinay , Hernandez Adrian V. , Uchino Ken 
Published: September 2017

Background and Purpose—
The incidence of periprocedural brain infarcts varies among cardiovascular procedures. In a systematic review, we compared the ratio of radiographic brain infarcts (RBI) to strokes and transient ischemic attacks across cardiac and vascular procedures.

Methods—
We searched MEDLINE and 5 other databases for brain infarcts in aortic valve replacement, coronary artery bypass grafting, cardiac catheterization, and cerebral angiogram through September 2015. We followed the PRISMA (preferred reporting items for systematic reviews and meta-analyses) recommendations. We defined symptomatic rate ratio (RR) as ratio of stroke plus transient ischemic attack rate to RBI rate.

Results—

Twenty-nine studies involving 2124 subjects met the inclusion criteria. In meta-analysis of aortic valve replacements with 494 people, 69.4% (95% confidence interval (CI), 57.6%–81.4%) had RBIs, whereas 3.6% (95% CI, 2.0%–5.2%) had clinical events (RR, 0.08; 95% CI, 0.05–0.12). Coronary artery bypass grafting among 204 patients had 27.4% (95% CI, 6.0%–48.8%) RBIs and 2.4% (95% CI, 0.3%–4.5%) clinical events (RR, 0.11; 95% CI, 0.05–0.26). Cardiac catheterization among 833 people had 8.0% (95% CI, 4.1%–12.0%) RBIs, and 0.6% (95% CI, 0.1%–1.1%) had clinical events (RR, 0.16; 95% CI, 0.08–0.31). Cerebral angiogram among 593 people had 12.8% (95% CI, 6.6–19.0) RBIs and 0.6% (95% CI, 0%–13%) clinical events (RR, 0.10; 95% CI, 0.04–0.27). The RR of all procedures was 0.10 (95% CI, 0.07–0.13) without differences in the RRs across procedures (
P
=0.29).

Conclusions—
One of 10 people with periprocedural RBIs during cardiac surgeries and invasive vascular diagnostic procedures resulted in strokes or transient ischemic attacks, which may serve as a potential surrogate marker of procedural proficiency and perhaps as a predictor of risk for periprocedural strokes.
Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting
Authors: Weimar Christian , Bilbilis Konstantinos , Rekowski Jan , Holst Torulv , Beyersdorf Friedhelm , Breuer Martin , Dahm Manfred , Diegeler Anno , Kowalski Arne , Martens Sven , Mohr Friedrich W. , Ondrášek Jiri , Reiter Beate , Roth Peter , Seipelt Ralf , Siggelkow Markus , Steinhoff Gustav , Moritz Anton , Wilhelmi Mathias , Wimmer-Greinecker Gerhard , Diener Hans-Christoph , Jakob Heinz , Ose Claudia , Scherag Andre , Knipp Stephan C. 
Published: September 2017

Background and Purpose—
The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG.

Methods—
Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days.

Results—

From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, −3.2% to 20.8%;
P
WALD
=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes.

Conclusions—
Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing.

Clinical Trial Registration—

URL:
https://www.controlled-trials.com
. Unique identifier: ISRCTN13486906.
Integrin α4 Overexpression on Rat Mesenchymal Stem Cells Enhances Transmigration and Reduces Cerebral Embolism After Intracarotid Injection
Authors: Cui Li-li , Nitzsche Franziska , Pryazhnikov Evgeny , Tibeykina Marina , Tolppanen Laura , Rytkönen Jussi , Huhtala Tuulia , Mu Jing-wei , Khiroug Leonard , Boltze Johannes , Jolkkonen Jukka 
Published: September 2017

Background and Purpose—
Very late antigen-4 (integrin α4β1)/vascular cell adhesion molecule-1 mediates leukocyte trafficking and transendothelial migration after stroke. Mesenchymal stem cells (MSCs) typically express integrin β1 but insufficient ITGA4 (integrin α4), which limits their homing after intravascular transplantation. We tested whether ITGA4 overexpression on MSCs increases cerebral homing after intracarotid transplantation and reduces MSC-borne cerebral embolism.

Methods—

Rat MSCs were lentivirally transduced to overexpress ITGA4. In vitro transendothelial migration was assessed using a Boyden chamber assay. Male Wistar rats intracarotidly received 0.5×10
6
control or modified MSCs 24 hours after sham or stroke surgery. In vivo behavior of MSCs in the cerebral vasculature was observed by intravital microscopy and single-photon emission computed tomography for up to 72 hours.

Results—
Transendothelial migration of ITGA4-overexpressing MSCs was increased in vitro. MSCs were passively entrapped in microvessels in vivo and occasionally formed large cell aggregates causing local blood flow interruptions. MSCs were rarely found in perivascular niches or parenchyma at 72 hours post-transplantation, but ITGA4 overexpression significantly decreased cell aggregation and ameliorated the evoked cerebral embolism in stroke rats.

Conclusions—
ITGA4 overexpression on MSCs enhances transendothelial migration in vitro, but not in vivo, although it improves safety after intracarotid transplantation into stroke rats.