Association of Operator and Hospital Experience With Procedural Success Rates and Outcomes in Patients Undergoing Percutaneous Coronary Interventions for Chronic Total Occlusions: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium

BACKGROUND: An inverse relationship has been described between procedural success and outcomes of all major cardiovascular procedures. However, this relationship has not been studied for percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). METHODS: We analyzed the data on patients enrolled in Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry in Michigan (January 1, 2010 to March 31, 2018) to evaluate the association of operator and hospital experience with procedural success and outcomes of patients undergoing CTO-PCI. CTO-PCI was defined as intervention of a 100% occluded coronary artery presumed to be ≥3 months old. RESULTS: Among 210 172 patients enrolled in the registry, 7389 (3.5%) CTO-PCIs were attempted with a success rate of 53%. CTO-PCI success increased with operator experience (45% and 65% in the lowest and highest experience tertiles) and was the highest for highly experienced operators at higher experience centers and the lowest for inexperienced operators at low experience hospitals. Multivariable logistic regression models (with spline transformed prior operator and institutional experience) demonstrated a positive relationship between prior operator and site experience and procedural success rates (likelihood ratio test=141.12, df=15, P\u3c0.001) but no relationship between operator and site experience and major adverse cardiac event (likelihood ratio test=19.12, df=15, P=0.208). CONCLUSIONS: Operator and hospital CTO-PCI experiences were directly related to procedural success but were not related to major adverse cardiac event among patients undergoing CTO-PCIs. Inexperienced operators at high experience centers had significantly higher success but not major adverse cardiac event rates compared with inexperienced operators at low experience centers. These data suggested that CTO-PCI safety and success could potentially be improved by selective referral of these procedures to experienced operators working at highly experienced centers

The initial U.S. experience with the Tempo active fixation temporary pacing lead in structural heart interventions

ObjectivesThis multicenter retrospective study of the initial U.S. experience evaluated the safety and efficacy of temporary cardiac pacing with the Tempo® Temporary Pacing Lead.BackgroundDespite 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.MethodsData 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.ResultsThe 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.ConclusionThe 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.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/154941/1/ccd28476.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/154941/2/ccd28476_am.pd

Enhanced Expression of p53 and Apoptosis Induced by Blockade of the Vacuolar Proton ATPase in Cardiomyocytes

Activation of the vacuolar proton ATPase (VPATPase) has been implicated in the prevention of apoptosis in neutrophils and adult cardiac myocytes. To determine the role of the VPATPase in apoptosis of cardiac myocytes, we used a potent and specific inhibitor of the VPATPase, bafilomycin A1. Bafilomycin A1 alone caused increased DNA laddering of genomic DNA and increased nuclear staining for fragmented DNA in neonatal cardiomyocyte apoptosis in a dose- and time-dependent manner. Intracellular acidification in cardiac myocytes was also observed after 18 h of bafilomycin A1 treatment. Accordingly, bafilomycin A1–treated myocytes also showed increased accumulation of p53 protein and p53-dependent transactivation of gene expression, including a persistent upregulation of p21/wild-type p53 activated fragment 1/cyclin kinase inhibitor protein-1 mRNA. The bafilomycin A1–induced increase in p53 protein levels was accompanied by a marked increase in p53 mRNA accumulation. In contrast, cardiac fibroblasts treated with bafilomycin A1 showed no change in p53 protein expression or pH i and did not undergo apoptosis even after 24 h of treatment. Our data suggest that blockade of the VPATPase induces apoptotic cell death of cardiac myocytes and that this may occur through a p53-mediated apoptotic pathway

Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomised trial

BackgroundFew studies have examined the efficacy of drug-eluting stents (DES) for reducing aortocoronary saphenous vein bypass graft (SVG) failure compared with bare-metal stents (BMS) in patients undergoing stenting of de-novo SVG lesions. We assessed the risks and benefits of the use of DES versus BMS in de-novo SVG lesions.MethodsPatients were recruited to our double-blind, randomised controlled trial from 25 US Department of Veterans Affairs centres. Eligible participants were aged at least 18 years and had at least one significant de-novo SVG lesion (50-99% stenosis of a 2·25-4·5 mm diameter SVG) requiring percutaneous coronary intervention with intent to use embolic protection devices. Enrolled patients were randomly assigned, in a 1:1 ratio, by phone randomisation system to receive a DES or BMS. Randomisation was stratified by presence or absence of diabetes and number of target SVG lesions requiring percutaneous coronary intervention (one or two or more) within each participating site by use of an adaptive scheme intended to balance the two stent type groups on marginal totals for the stratification factors. Patients, referring physicians, study coordinators, and outcome assessors were masked to group allocation. The primary endpoint was the 12-month incidence of target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularisation. The DIVA trial is registered with ClinicalTrials.gov, number NCT01121224.FindingsBetween Jan 1, 2012, and Dec 31, 2015, 599 patients were randomly assigned to the stent groups, and the data for 597 patients were used. The patients' mean age was 68·6 (SD 7·6) years, and 595 (>99%) patients were men. The two stent groups were similar for most baseline characteristics. At 12 months, the incidence of target vessel failure was 17% (51 of 292) in the DES group versus 19% (58 of 305) in the BMS group (adjusted hazard ratio 0·92, 95% CI 0·63-1·34, p=0·70). Between-group differences in the components of the primary endpoint, serious adverse events, or stent thrombosis were not significant. Enrolment was stopped before the revised target sample size of 762 patients was reached.InterpretationIn patients undergoing stenting of de-novo SVG lesions, no significant differences in outcomes between those receiving DES and BMS during 12 months of follow-up were found. The study results have important economic implications in countries with high DES prices such as the USA, because they suggest that the lower-cost BMS can be used in SVG lesions without compromising either safety or efficacy.FundingUS Department of Veterans Affairs Cooperative Studies Program