Risk profiles and outcomes of patients receiving antibacterial cardiovascular implantable electronic device envelopes:A retrospective analysis

BACKGROUND Cardiovascular implantable electronic devices(CIEDs)are implanted in an increasing number of patients each year,which has led to an increase in the risk of CIED infection.Antibacterial CIED envelopes locally deliver antibiotics to the implant site over a short-term period and have been shown to reduce the risk of implant site infection.These envelopes are derived from either biologic or nonbiologic materials.There is a paucity of data examining patient risk profiles and outcomes from using these envelope materials in the clinical setting and comparing these results to patients receiving no envelope with their CIED implantation.AIM To evaluate risk profiles and outcomes of patients who underwent CIED procedures with an antibacterial envelope or no envelope.METHODS After obtaining Internal Review Board approval,the records of consecutive patients who underwent a CIED implantation procedure by a single physician between March 2017 and December 2019 were retrospectively collected from our hospital.A total of 248 patients within this period were identified and reviewed through 12 mo of follow up.The CIED procedures used either no envelope(n=57),a biologic envelope(CanGaroo®,Aziyo Biologics)that was pre-hydrated by the physician with vancomycin and gentamicin(n=89),or a non-biologic envelope(Tyrx^(TM),Medtronic)that was coated with a resorbable polymer containing the drug substances rifampin and minocycline by the manufacturer(n=102).Patient selection for receiving either no envelope or an envelope(and which envelope to use)was determined by the treating physician.Statistical analyses were performed between the 3 groups(CanGaroo,Tyrx,and no envelope),and also between the No Envelope and Any Envelope groups by an independent,experienced biostatistician.RESULTS On average,patients who received any envelope(biologic or non-biologic)were younger(70.7±14.0 vs 74.9±10.6,P=0.017),had a greater number of infection risk factors(81.2%vs 49.1%,P<0.001),received more high-powered devices(37.2%vs 5.8%,P=0.004),and were undergoing more reoperative procedures(47.1%vs 0.0%,P<0.001)than patients who received no envelope.Between the two envelopes,biologic envelopes tended to be used more often in higher risk patients(84.3%vs 78.4%)and reoperative procedures(62.9%vs 33.3%)than non-biologic envelopes.The rate of CIED implant site pocket infection was low(any envelope 0.5%vs no envelope 0.0%)and was statistically equivalent between the two envelope groups.Other reported adverse events(lead dislodgement,lead or pocket revision,device migration or erosion,twiddler’s syndrome,and erythema/fever)were low and statistically equivalent between groups(biologic 2.2%,non-biologic 3.9%,no envelope 1.8%).CONCLUSION CIED infection rates for biologic and non-biologic antibacterial envelopes are similar.Antibacterial envelopes may benefit patients who are higher risk for infection,however additional studies are warranted to confirm this.

Effect of fluoroscopy frame rate on radiation exposure and in-hospital outcomes in cardiovascular implantable electronic device implantation procedures

Objective:To assess the radiation exposure in cardiovascular implantable electronic device(CIED)implantation procedures,the effect of fluoroscopy frame rate on various radiation exposure indices,and in-hospital outcomes.Methods:Data of CIED implantation procedures from September 2015 to December 2019 of all the CIED implantation procedures performed at our institute were retrospectively analyzed.The procedural data were divided into two groups:a)pre-group:procedures that were performed under fluoroscopy frame rate of 7.5 frames per second(fps);b)post-group:procedures that were performed under fluoroscopy frame rate of 3.75 fps.We compared procedure time,fluoroscopy time,Kerma air product,effective dose,and in-hospital outcomes between the two groups.Results:A total of 2,225 procedures were included in the analysis with mean age of(62±15)years.The procedures consisted of the implantation of single-chamber(n=1,436),double chamber(n=656),and biventricular devices(n=133).Procedure time and radiation indices showed a significant reduction over the study period(P<0.001).Reduction in the fluoroscopy frame rate was associated with a significant reduction in radiation exposure indices(P<0.001).In-hospital outcomes did not differ between the two groups.Conclusions:Reduction in the fluoroscopy frame rate from 7.5 to 3.75 fps significantly decreased the radiation exposure in CIED implantation procedures.A framerate lower than 3.75 fps should be the default setting during such procedures.

Optimized Axillary Vein Technique versus Subclavian Vein Technique in Cardiovascular Implantable Electronic Device Implantation： A Randomized Controlled Study

Background：The conventional venous access for cardiovascular implantable electronic device （CIED） is the subclavian vein,which is often accompanied by high complication rate.The aim of this study was to assess the efficacy and safety of optimized axillary vein technique.Methods：A total of 247 patients undergoing CIED implantation were included and assigned to the axillary vein group or the subclavian vein group randomly.Success rate of puncture and complications in the perioperative period and follow-ups were recorded.Results：The overall success rate （95.7% vs.96.0%） and one-time success rate （68.4% vs.66.1%） of punctures were similar between the two groups.In the subclavian vein group,pneumothorax occurred in three patients.The subclavian gaps of three patients were too tight to allow operation of the electrode lead.In contrast,there were no puncture-associated complications in the axillary vein group.In the patient follow-ups,two patients in the subclavian vein group had subclavian crush syndrome and both of them received lead replacement.The incidence of complications during the perioperative period and follow-ups of the axillary vein group and the subclavian vein group was 1.6% （2/125） and 8.2% （10/122）,respectively （χ^2=5.813,P =0.016）.Conclusion：Optimized axillary vein technique may be superior to the conventional subclavian vein technique for CIED lead placement.