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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The incidence of infection in cardiac implantable electronic devices &#40;CIEDs&#41; is increasing at a faster rate than device implantation rates&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">1</span></a> This is mostly due to older patients being implanted with more complex CIEDs and the fact that guidelines have significantly broadened the eligibility criteria for the use of CIEDs&#44; now including patients with more comorbidities&#44; who have a greater risk of infection&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Infection is one of the most serious complications of CIED therapy and is associated with significant mortality and morbidity&#46; Patients undergoing extraction for a systemic-related device infection have about 25&#37; one-year mortality despite successful extraction&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">2</span></a> Another important consequence is the burden imposed on healthcare systems due to prolonged hospitalization&#44; increased use of antibiotics&#44; the need for device removal&#44; as well as CIED reimplantation&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Infections in CIEDs&#44; including pacemakers&#44; cardiac resynchronization therapy devices and implantable cardioverter-defibrillators &#40;ICDs&#41;&#44; can occur as a complication of device implantation&#44; but occurs more often following revisions&#44; upgrades and device replacements&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">4</span></a> These infections are usually caused by bacteria entering the body during the procedure&#44; but also&#44; via the bloodstream or through the skin after a pressure lesion develops around the implant area&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Risk factors for CIED infection may be divided into patient-related&#44; procedure-related&#44; and device-related factors&#46; The most common risk factors for infection&#44; as well as factors of high clinical impact&#44; have long been known&#58; end-stage renal dysfunction&#44; prior device infection&#44; fever prior to implantation&#44; corticosteroid use&#44; renal insufficiency&#44; procedure duration&#44; hematoma&#44; early reintervention&#44; epicardial leads and diabetes&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">5</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">It is important to understand that recognition of these risk factors should be taken into consideration when deciding on the type of device chosen to treat different medical conditions&#46; The availability of different technologies also means treatment can be tailored according to the risk of infection&#46; Some of these technologies&#44; like leadless pacing and extravascular ICDs&#44; can significantly reduce or eliminate&#44; respectively&#44; the risk of intravascular infections&#46; In the presence of infection&#44; management of patients with extravascular ICDs is less challenging and as a result&#44; mortality is diminished&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Prevention of infections is key&#46; In order to optimize outcomes&#44; preventative routine measures should be performed&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Patients should be screened for active infection and antibiotics should be administered before the implantation procedure to prevent bacterial contamination &#40;within 1 h of incision for cefazolin and flucloxacillin&#44; within 90&#8211;120 min for vancomycin&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">5</span></a></p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0040" class="elsevierStylePara elsevierViewall">Sterile techniques during the implantation procedure should be optimized and assessed regularly&#46; Surgical facilities should be routinely assessed and improved for better outcomes&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0045" class="elsevierStylePara elsevierViewall">Use of a prophylactic antibiotic envelope reduces the early risk of infection&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Incisions and final stitching should routinely be performed as far as possible from all hardware components of the CIED&#44; especially in device replacements&#44; in which the risk of infection is higher&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0055" class="elsevierStylePara elsevierViewall">Unnecessary central or peripheral catheters should be removed as soon as possible after or even before device implantation&#46; Whenever this cannot be achieved&#44; extra careful aseptic management of these infection entry points is recommended&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">&#8226;</span><p id="par0060" class="elsevierStylePara elsevierViewall">Patients with CIEDs should have early follow-up visits to detect any signs of early post-implantation superficial infection of the surgical wound that can be treated with antibiotics&#44; before the infection reaches any component of the CIED&#46;</p></li></ul></p><p id="par0065" class="elsevierStylePara elsevierViewall">It is important to highlight that despite these measures&#44; CIED pocket infections will occur&#46; Therefore&#44; prompt diagnosis and treatment are essential to prevent serious complications such as sepsis or death&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Local administration of antiseptics and antibiotics in the pocket during device implantation is still controversial&#59; according to the EHRA consensus document&#44; this practice is contraindicated&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">6</span></a> The same document recommends the use of antibiotic envelopes in patients at high risk of infection&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">6</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">Studies of multiple surgical procedures have reported reduced infection rates with the local application of antibiotics&#46; Based on this evidence&#44; the microbiology of CIED infections&#44; and bactericidal data&#44; current CIED envelope devices use either rifampin&#47;minocycline or gentamicin for infection prophylaxis&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The TYRX Antibacterial Absorbable Envelope is a medical device designed to reduce the risk of infection associated with CIED implantation&#46; The envelope is made of a mesh material that contains rifampin and minocycline&#44; which are released over time to prevent bacterial colonization and biofilm formation around the device&#46; It is fully absorbed within approximately nine weeks of implantation&#46; This is probably the most extensively studied medical device developed specifically for this purpose&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">A prospective multicenter randomized clinical trial published in the <span class="elsevierStyleItalic">New England Journal of Medicine</span> &#40;WRAP-IT 2019&#41;&#44; with 6983 patients &#40;3495 to the envelope group and 3488 to the control group&#41;&#44; demonstrated that adjunctive use of an antibacterial envelope resulted in a 40&#37; lower incidence of major CIED infection than standard-of-care infection-prevention strategies alone at 12 months of the procedure &#40;event rate was 0&#46;7&#37; vs&#46; 1&#46;2&#37;&#44; respectively&#59; p&#61;0&#46;04&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">7</span></a></p><p id="par0090" class="elsevierStylePara elsevierViewall">In addition&#44; long-term follow-up &#40;36 months&#41; of WRAP-IT reported major CIED-related infections in 32 envelope patients and 51 control patients &#40;Kaplan-Meier &#91;KM&#93; estimate 1&#46;3&#37; vs&#46; 1&#46;9&#37;&#59; hazard ratio &#91;HR&#93; 0&#46;64&#59; 95&#37; confidence interval &#91;CI&#93; 0&#46;41&#8211;0&#46;99&#59; p&#61;0&#46;046&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">8</span></a> Any CIED-related infection occurred in 57 envelope patients and 84 control patients &#40;KM estimate 2&#46;1&#37; vs&#46; 2&#46;8&#37;&#59; HR 0&#46;69&#59; 95&#37; CI 0&#46;49&#8211;0&#46;97&#59; p&#61;0&#46;030&#41;&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">Although the results of the WRAP-IT trial achieved statistical significance &#40;i&#46;e&#46;&#44; p&#60;0&#46;05&#41;&#44; the findings were not as robust as expected&#44; due to a lower than anticipated overall infection rate&#46; Moreover&#44; the number needed to treat in this trial to prevent one CIED infection was 200 patients&#44; a large number compared to other preventive therapies&#46; Therefore&#44; further refinements are needed to optimize the clinical benefits and costs of these novel envelopes&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">Overall&#44; the available evidence suggests that the TYRX Antibacterial Envelope is an effective measure for reducing the risk of CIED infections&#46; However&#44; further independent studies may be needed to confirm these findings and to evaluate the device&#39;s long-term safety and effectiveness&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">Although the TYRX is the best-known medical device in this field&#44; there are other similar devices that are designed to reduce the risk of infection&#46; These include&#58;<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">&#8226;</span><p id="par0110" class="elsevierStylePara elsevierViewall">The AigisRx Antibacterial Envelope is the previous generation of the TYRX device and is also designed to release antimicrobial agents to prevent bacterial colonization and biofilm formation around the CIED&#46; It contains a silver-based antimicrobial agent and is made of a non-absorbable mesh material&#46; The fact of being non-absorbable constitutes one of the major differences from its successor&#44; the TYRX&#44; a characteristic that can become troublesome when device replacement becomes necessary&#46;</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">&#8226;</span><p id="par0115" class="elsevierStylePara elsevierViewall">The CanGaroo&#174; envelope is composed of decellularized extracellular matrix and was originally designed to stabilize the device within the pocket&#44; limiting the risk of migration or erosion&#44; and providing a substrate for tissue ingrowth&#46; This device has shown promising results in a preclinical study and clinical studies with local delivery of gentamicin&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">9</span></a></p></li></ul></p><p id="par0120" class="elsevierStylePara elsevierViewall">Like the TYRX&#44; these devices have shown to be effective in reducing the risk of CIED infections&#44; however further studies may be needed to confirm their safety and effectiveness and in different patient populations and settings&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Future research that can determine the efficacy of new devices&#44; as well as older technologies such as gentamicin-impregnated collagen sponges &#40;GICSs&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">10</span></a> that can be used in different settings from those they were initially produced for&#44; is of paramount importance&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">The article by Matteucci et al&#46; published in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">11</span></a> is an interesting example of a wise and practical approach with excellent results for the use of a device created and normally employed for reducing cardiac surgery wound infections&#44; here applied in the prevention of CIED infection&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">In this study&#44; 2986 patients were randomized over a 10-year period&#44; of whom 919 had additional treatment with GICSs and 2067 in the control group received only standard care with prophylactic antibiotics&#46; The study&#39;s endpoints were the CIED infection rate at one year and the effectiveness of the use of GICSs in reducing CIED infection&#46; It was demonstrated that adjunctive use of GICSs resulted in a reduction of the percentage of infected patients&#46; CIED-related infections occurred in a total of 36 patients &#40;1&#46;2&#37;&#41;&#59; 30&#46;8&#37; of all non-infected patients received GICS therapy versus 13&#46;9&#37; of those in the infected group&#46; Efficacy was statistically significant in treated patients &#40;p&#60;0&#46;001&#44; 95&#37; CI&#58; 0&#46;03&#8211;0&#46;001&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">11</span></a> This study demonstrated for the first time that GICSs are effective in reducing CIED infection&#44; although their efficacy needs to be tested in randomized trials before they become routine practice&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">It is essential to broaden the portfolio of this type of medical device&#46; Increasing the availability and variety of such devices will mean that they can be more widely used and accessible at a lower cost&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">New devices and large prospective studies are needed to help refine indications and to support judicious use of antibiotic envelopes to prevent CIED infection&#46; This will certainly contribute to better treatments for reducing CIED infection&#44; a complication that is growing at disproportionate speed and deserves our best efforts in order to reduce the burden of CIED-related side-effects&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0150" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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Cardiac implantable electronic device infections: An overwhelming tsunami
Infeções em dispositivos cardíacos eletrónicos implantáveis: um tsunami devastador
Bruno Tereno Valente
Centro Hospitalar Universitário de Lisboa Central, Hospital de Santa Marta, Lisboa, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The incidence of infection in cardiac implantable electronic devices &#40;CIEDs&#41; is increasing at a faster rate than device implantation rates&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">1</span></a> This is mostly due to older patients being implanted with more complex CIEDs and the fact that guidelines have significantly broadened the eligibility criteria for the use of CIEDs&#44; now including patients with more comorbidities&#44; who have a greater risk of infection&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">Infection is one of the most serious complications of CIED therapy and is associated with significant mortality and morbidity&#46; Patients undergoing extraction for a systemic-related device infection have about 25&#37; one-year mortality despite successful extraction&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">2</span></a> Another important consequence is the burden imposed on healthcare systems due to prolonged hospitalization&#44; increased use of antibiotics&#44; the need for device removal&#44; as well as CIED reimplantation&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Infections in CIEDs&#44; including pacemakers&#44; cardiac resynchronization therapy devices and implantable cardioverter-defibrillators &#40;ICDs&#41;&#44; can occur as a complication of device implantation&#44; but occurs more often following revisions&#44; upgrades and device replacements&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">4</span></a> These infections are usually caused by bacteria entering the body during the procedure&#44; but also&#44; via the bloodstream or through the skin after a pressure lesion develops around the implant area&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Risk factors for CIED infection may be divided into patient-related&#44; procedure-related&#44; and device-related factors&#46; The most common risk factors for infection&#44; as well as factors of high clinical impact&#44; have long been known&#58; end-stage renal dysfunction&#44; prior device infection&#44; fever prior to implantation&#44; corticosteroid use&#44; renal insufficiency&#44; procedure duration&#44; hematoma&#44; early reintervention&#44; epicardial leads and diabetes&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">5</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">It is important to understand that recognition of these risk factors should be taken into consideration when deciding on the type of device chosen to treat different medical conditions&#46; The availability of different technologies also means treatment can be tailored according to the risk of infection&#46; Some of these technologies&#44; like leadless pacing and extravascular ICDs&#44; can significantly reduce or eliminate&#44; respectively&#44; the risk of intravascular infections&#46; In the presence of infection&#44; management of patients with extravascular ICDs is less challenging and as a result&#44; mortality is diminished&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Prevention of infections is key&#46; In order to optimize outcomes&#44; preventative routine measures should be performed&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Patients should be screened for active infection and antibiotics should be administered before the implantation procedure to prevent bacterial contamination &#40;within 1 h of incision for cefazolin and flucloxacillin&#44; within 90&#8211;120 min for vancomycin&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">5</span></a></p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0040" class="elsevierStylePara elsevierViewall">Sterile techniques during the implantation procedure should be optimized and assessed regularly&#46; Surgical facilities should be routinely assessed and improved for better outcomes&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0045" class="elsevierStylePara elsevierViewall">Use of a prophylactic antibiotic envelope reduces the early risk of infection&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Incisions and final stitching should routinely be performed as far as possible from all hardware components of the CIED&#44; especially in device replacements&#44; in which the risk of infection is higher&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0055" class="elsevierStylePara elsevierViewall">Unnecessary central or peripheral catheters should be removed as soon as possible after or even before device implantation&#46; Whenever this cannot be achieved&#44; extra careful aseptic management of these infection entry points is recommended&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">&#8226;</span><p id="par0060" class="elsevierStylePara elsevierViewall">Patients with CIEDs should have early follow-up visits to detect any signs of early post-implantation superficial infection of the surgical wound that can be treated with antibiotics&#44; before the infection reaches any component of the CIED&#46;</p></li></ul></p><p id="par0065" class="elsevierStylePara elsevierViewall">It is important to highlight that despite these measures&#44; CIED pocket infections will occur&#46; Therefore&#44; prompt diagnosis and treatment are essential to prevent serious complications such as sepsis or death&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Local administration of antiseptics and antibiotics in the pocket during device implantation is still controversial&#59; according to the EHRA consensus document&#44; this practice is contraindicated&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">6</span></a> The same document recommends the use of antibiotic envelopes in patients at high risk of infection&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">6</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">Studies of multiple surgical procedures have reported reduced infection rates with the local application of antibiotics&#46; Based on this evidence&#44; the microbiology of CIED infections&#44; and bactericidal data&#44; current CIED envelope devices use either rifampin&#47;minocycline or gentamicin for infection prophylaxis&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The TYRX Antibacterial Absorbable Envelope is a medical device designed to reduce the risk of infection associated with CIED implantation&#46; The envelope is made of a mesh material that contains rifampin and minocycline&#44; which are released over time to prevent bacterial colonization and biofilm formation around the device&#46; It is fully absorbed within approximately nine weeks of implantation&#46; This is probably the most extensively studied medical device developed specifically for this purpose&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">A prospective multicenter randomized clinical trial published in the <span class="elsevierStyleItalic">New England Journal of Medicine</span> &#40;WRAP-IT 2019&#41;&#44; with 6983 patients &#40;3495 to the envelope group and 3488 to the control group&#41;&#44; demonstrated that adjunctive use of an antibacterial envelope resulted in a 40&#37; lower incidence of major CIED infection than standard-of-care infection-prevention strategies alone at 12 months of the procedure &#40;event rate was 0&#46;7&#37; vs&#46; 1&#46;2&#37;&#44; respectively&#59; p&#61;0&#46;04&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">7</span></a></p><p id="par0090" class="elsevierStylePara elsevierViewall">In addition&#44; long-term follow-up &#40;36 months&#41; of WRAP-IT reported major CIED-related infections in 32 envelope patients and 51 control patients &#40;Kaplan-Meier &#91;KM&#93; estimate 1&#46;3&#37; vs&#46; 1&#46;9&#37;&#59; hazard ratio &#91;HR&#93; 0&#46;64&#59; 95&#37; confidence interval &#91;CI&#93; 0&#46;41&#8211;0&#46;99&#59; p&#61;0&#46;046&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">8</span></a> Any CIED-related infection occurred in 57 envelope patients and 84 control patients &#40;KM estimate 2&#46;1&#37; vs&#46; 2&#46;8&#37;&#59; HR 0&#46;69&#59; 95&#37; CI 0&#46;49&#8211;0&#46;97&#59; p&#61;0&#46;030&#41;&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">Although the results of the WRAP-IT trial achieved statistical significance &#40;i&#46;e&#46;&#44; p&#60;0&#46;05&#41;&#44; the findings were not as robust as expected&#44; due to a lower than anticipated overall infection rate&#46; Moreover&#44; the number needed to treat in this trial to prevent one CIED infection was 200 patients&#44; a large number compared to other preventive therapies&#46; Therefore&#44; further refinements are needed to optimize the clinical benefits and costs of these novel envelopes&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">Overall&#44; the available evidence suggests that the TYRX Antibacterial Envelope is an effective measure for reducing the risk of CIED infections&#46; However&#44; further independent studies may be needed to confirm these findings and to evaluate the device&#39;s long-term safety and effectiveness&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">Although the TYRX is the best-known medical device in this field&#44; there are other similar devices that are designed to reduce the risk of infection&#46; These include&#58;<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">&#8226;</span><p id="par0110" class="elsevierStylePara elsevierViewall">The AigisRx Antibacterial Envelope is the previous generation of the TYRX device and is also designed to release antimicrobial agents to prevent bacterial colonization and biofilm formation around the CIED&#46; It contains a silver-based antimicrobial agent and is made of a non-absorbable mesh material&#46; The fact of being non-absorbable constitutes one of the major differences from its successor&#44; the TYRX&#44; a characteristic that can become troublesome when device replacement becomes necessary&#46;</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">&#8226;</span><p id="par0115" class="elsevierStylePara elsevierViewall">The CanGaroo&#174; envelope is composed of decellularized extracellular matrix and was originally designed to stabilize the device within the pocket&#44; limiting the risk of migration or erosion&#44; and providing a substrate for tissue ingrowth&#46; This device has shown promising results in a preclinical study and clinical studies with local delivery of gentamicin&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">9</span></a></p></li></ul></p><p id="par0120" class="elsevierStylePara elsevierViewall">Like the TYRX&#44; these devices have shown to be effective in reducing the risk of CIED infections&#44; however further studies may be needed to confirm their safety and effectiveness and in different patient populations and settings&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Future research that can determine the efficacy of new devices&#44; as well as older technologies such as gentamicin-impregnated collagen sponges &#40;GICSs&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">10</span></a> that can be used in different settings from those they were initially produced for&#44; is of paramount importance&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">The article by Matteucci et al&#46; published in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">11</span></a> is an interesting example of a wise and practical approach with excellent results for the use of a device created and normally employed for reducing cardiac surgery wound infections&#44; here applied in the prevention of CIED infection&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">In this study&#44; 2986 patients were randomized over a 10-year period&#44; of whom 919 had additional treatment with GICSs and 2067 in the control group received only standard care with prophylactic antibiotics&#46; The study&#39;s endpoints were the CIED infection rate at one year and the effectiveness of the use of GICSs in reducing CIED infection&#46; It was demonstrated that adjunctive use of GICSs resulted in a reduction of the percentage of infected patients&#46; CIED-related infections occurred in a total of 36 patients &#40;1&#46;2&#37;&#41;&#59; 30&#46;8&#37; of all non-infected patients received GICS therapy versus 13&#46;9&#37; of those in the infected group&#46; Efficacy was statistically significant in treated patients &#40;p&#60;0&#46;001&#44; 95&#37; CI&#58; 0&#46;03&#8211;0&#46;001&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">11</span></a> This study demonstrated for the first time that GICSs are effective in reducing CIED infection&#44; although their efficacy needs to be tested in randomized trials before they become routine practice&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">It is essential to broaden the portfolio of this type of medical device&#46; Increasing the availability and variety of such devices will mean that they can be more widely used and accessible at a lower cost&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">New devices and large prospective studies are needed to help refine indications and to support judicious use of antibiotic envelopes to prevent CIED infection&#46; This will certainly contribute to better treatments for reducing CIED infection&#44; a complication that is growing at disproportionate speed and deserves our best efforts in order to reduce the burden of CIED-related side-effects&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0150" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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