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Indian Journal of Plastic Surgery :... Sep 2021Infection of cardiac implantable electrical devices (CIEDs) may lead to serious complications. Complete CIED explantation is expensive, requires expertise, not free...
Infection of cardiac implantable electrical devices (CIEDs) may lead to serious complications. Complete CIED explantation is expensive, requires expertise, not free from complications, and may not be an option in patients with device dependence. To highlight that carefully selected infected CIEDs can be salvaged by placing the device in a subpectoral pocket below the pectoralis major muscle. We conducted a retrospective descriptive observational study. Twelve patients (10 male and two female) with erosion, exposure or infection of infraclavicular, subcutaneously placed CIED were treated over a 30-month period between July 2018 and December 2020. The technique involved debridement and excision of a peridevice capsule, creating a subpectoral pocket beneath the pectoralis major muscle, and placing the CIED in a new pocket with total muscle coverage and closure of skin without tension. Twelve patients ( = 10; = 2) with a mean age of 65 years (range, 46-82 years) presented with infection of CIED within 9 months of implantation. None had sepsis or endocarditis. In nine patients, CIEDs were successfully salvaged with relocation to subpectoral pocket. Mean follow-up was 20 months (range, 8-30 months). Three out of 12 developed reinfection that ultimately required CIED explantation. There was no mortality. In the absence of sepsis or endocarditis, infected CIEDs may be attempted at salvage by subpectoral pocket placement. This obviates the need for potentially risky explantation or replacement of expensive CIEDs.
PubMed: 34667522
DOI: 10.1055/s-0041-1735417 -
World Journal of Cardiology Mar 2022Cardiovascular 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...
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 non-biologic 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 ( = 57), a biologic envelope (CanGaroo, Aziyo Biologics) that was pre-hydrated by the physician with vancomycin and gentamicin ( = 89), or a non-biologic envelope (Tyrx™, Medtronic) that was coated with a resorbable polymer containing the drug substances rifampin and minocycline by the manufacturer ( = 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 74.9 ± 10.6, = 0.017), had a greater number of infection risk factors (81.2% 49.1%, < 0.001), received more high-powered devices (37.2% 5.8%, = 0.004), and were undergoing more reoperative procedures (47.1% 0.0%, < 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% 78.4%) and reoperative procedures (62.9% 33.3%) than non-biologic envelopes. The rate of CIED implant site pocket infection was low (any envelope 0.5% 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.
PubMed: 35432770
DOI: 10.4330/wjc.v14.i3.177 -
Indian Journal of Otolaryngology and... Aug 2022Ossicular discontinuity is the most common cause of conductive hearing loss. The use of ossicular graft material in ossicular chain reconstruction significantly improves...
Ossicular discontinuity is the most common cause of conductive hearing loss. The use of ossicular graft material in ossicular chain reconstruction significantly improves the result in hearing. This study was conducted to compare and analyze the outcome of ossicular reconstruction using allogenic septal spur cartilage and autologous cortical bone in terms of hearing results and graft uptake rates. Study design: randomized clinical trial. Study included 112 patients visiting our ENT department. Patients between 16 and 50 years of age with history of chronic ear discharge and air-bone-gap (ABG) of > 35 dB and ossicular involvement were included in the study. The patients underwent detailed ENT examination, audiological and radiological assessment of temporal bone and those patients with evidence of ossicular erosion were subjected to ossiculoplasty with allogenic septal spur cartilage (group I) and autologous cortical bone (group II) randomly. The patients were followed up to 6 months to analyze functional and anatomical results. 50 patients out of 56 patients (90%) from group I who underwent allogenic septal cartilage ossicular reconstruction showed significant improvement in hearing as assessed by pure tone audiogram after 3 months and 6 months. Remaining 10% of patients who did not show hearing improvement on PTA were reopened after 6 months. It was observed that the stapes head got necrosed in them. 40 patients (72%) out of 56 patients (50%) from group II who underwent autologous cortical bone reconstruction showed hearing improvement. Remaining 16 patients (28%) showed no hearing improvement. They were reopened and ankylosis, dislocation of ossicle and extrusion were noted. In our study, graft uptake rates, formation of retraction pockets, and hearing improvements were analyzed. Complications like ankylosis formation, dislocation of ossicle and extrusion rates were more in the group II compared to group I. Hearing results of group I are better compared to group II and the allogenic septal cartilage being readily available is a good option for ossicular reconstruction.
PubMed: 36032828
DOI: 10.1007/s12070-020-01924-8 -
Cureus Dec 2020The standard of care for device infection is normally a complete removal of the implantable system, including lead extraction in local or systemic infection cases....
The standard of care for device infection is normally a complete removal of the implantable system, including lead extraction in local or systemic infection cases. Despite the importance of lead extraction techniques, these techniques are complex and have some major risks. Success rates were high, but they are less favorable in patients with several comorbidities. An 80-year-old male presented for device erosion. The patient is known to have several cardiac comorbidities: a transcatheter aortic valve replacement (TAVR), mitral clips for severe aortic stenosis, mitral regurgitation, dual-chamber implantable cardioverter defibrillators (ICD) for secondary prevention. Several weeks ago, he noted tenderness and redness at the site of his device pocket, and his physician, after checking his wound, suggested a possible skin irritation with no systemic infection and started antibiotics treatment. Two weeks later, he noted thinning of the skin around the device with a hematoma and ecchymosis, and slight skin erosion. Strategies for assessment of the wound and pocket cleaning were taken. The strategy was to remove the left-sided device and keep the leads since the patient lately has no elevated inflammatory labs, negative cultures, no fever, nor signs of vegetation on transesophageal echocardiography (TEE) and refused any additional examination as positron emission tomography (PET) scan, and reimplant a new system on the contralateral side. The procedure was divided into two sequences: extracting the device and after one-week implantation of a right-sided new system. In this case, chronic antibiotics were discussable to decrease the recurrence rate, but they did increase the severity of the patient's thrombocytopenia. Despite extraction being the gold standard of treatment in most cases of devices with local and systemic infection, there are some frail patients with several comorbidities where extraction is unbearable due to its major risks and complex procedure. In these specific cases with local infection and device erosion with no signs of any systemic infection, conservative therapy could be a viable option.
PubMed: 33457133
DOI: 10.7759/cureus.12032 -
Molecular Pharmaceutics May 2021Except for routine scaling and root planing, there are few effective nonsurgical therapeutic interventions for periodontitis and associated alveolar bone loss....
Except for routine scaling and root planing, there are few effective nonsurgical therapeutic interventions for periodontitis and associated alveolar bone loss. Simvastatin (SIM), one of the 3-hydroxy-3-methylglutaryl-cosenzyme A reductase inhibitors, which is known for its capacity as a lipid-lowering medication, has been proven to be an effective anti-inflammatory and bone anabolic agent that has shown promising benefits in mitigating periodontal bone loss. The local delivery of SIM into the periodontal pocket, however, has been challenging due to SIM's poor water solubility and its lack of osteotropicity. To overcome these issues, we report a novel SIM formulation of a thermoresponsive, osteotropic, injectable hydrogel (PF127) based on pyrophosphorolated pluronic F127 (F127-PPi). After mixing F127-PPi with F127 at a 1:1 ratio, the resulting PF127 was used to dissolve free SIM to generate the SIM-loaded formulation. The thermoresponsive hydrogel's rheologic behavior, erosion and SIM release kinetics, osteotropic property, and biocompatibility were evaluated . The therapeutic efficacy of SIM-loaded PF127 hydrogel on periodontal bone preservation and inflammation resolution was validated in a ligature-induced periodontitis rat model. Given that SIM is already an approved medication for hyperlipidemia, the data presented here support the translational potential of the SIM-loaded PF127 hydrogel for better clinical management of periodontitis and associated pathologies.
Topics: Alveolar Bone Loss; Alveolar Process; Animals; Drug Carriers; Drug Liberation; Female; Humans; Hydrogels; Injections, Intralesional; Mice; Models, Animal; Periodontitis; Poloxamer; RAW 264.7 Cells; Rats; Simvastatin; Solubility; X-Ray Microtomography
PubMed: 33754729
DOI: 10.1021/acs.molpharmaceut.0c01196 -
Journal of Cardiothoracic Surgery Sep 2020Pocket-related complications following the implantation of cardiovascular implantable electronic devices primarily include pocket hematoma, infection, skin erosion or...
BACKGROUND
Pocket-related complications following the implantation of cardiovascular implantable electronic devices primarily include pocket hematoma, infection, skin erosion or decubitus, device migration, and Twiddler's syndrome, with other pathologies such as nerve impairment or bone lesions being extremely rarely encountered. We report a case of a 20-year old asthenic, non-athlete female patient presenting with a device-generated fracture of the second rib several months after sub-muscular permanent pacemaker implantation due to repeated bilateral pre-pectoral pocket infections.
CASE PRESENTATION
A 20-year old female patient was readmitted to our institution 9 months following sub-pectoral implantation of a permanent pacemaker, complaining of severe pocket-related pain, which arose spontaneously in the absence of direct trauma, intense physical activity or vigorous coughing, and was associated with normal day-to-day activity. To rule out a pacemaker re-infection, a native computed tomography and a positron emission tomography-computed tomography of the thorax were performed. Both modalities excluded an infection but showed a healing fracture and a focus of enhanced metabolic activity in the anterolateral part of the right second rib, indicating a non-traumatic or stress fracture of the bone. Consequently, a complete extraction of the pulse generator and both leads was performed and the smallest available single-chamber pulse generator with a single atrial electrode was implanted in the sub-fascial, pre-muscular pocket in the now recovered and uninfected left subclavicular region, alleviating patient's severe pain symptoms and significantly enhancing her quality of life.
CONCLUSIONS
In the absence of direct trauma, intense physical activity or vigorous coughing, we assume that in this asthenic girl a normal day-to-day motion of the right shoulder has persistently forced the sub-muscularly placed pulse generator toward thoracic wall, putting increased repetitive pressure force on the underlying bones, finally causing a fatigue stress fracture of the second rib. In asthenic phenotype patients with small thorax and short subclavicular distance, a sub-muscular pacemaker implantation can potentially cause unique and unexpected pocket-related adverse events necessitating advanced diagnostics and timely treatment.
Topics: Diagnosis, Differential; Female; Fractures, Stress; Humans; Pacemaker, Artificial; Postoperative Complications; Quality of Life; Rib Fractures; Tomography, X-Ray Computed; Young Adult
PubMed: 32938486
DOI: 10.1186/s13019-020-01303-y -
Journal of Cardiology Cases Aug 2022Total extrusion of a pacemaker is rare and may result from skin and/or pocket infection or skin erosion because of fragility caused by actions such as scratching an...
UNLABELLED
Total extrusion of a pacemaker is rare and may result from skin and/or pocket infection or skin erosion because of fragility caused by actions such as scratching an itch. Total extrusion of a pacemaker may cause fatal arrhythmias, exacerbation of heart failure, and infection. We report the case of a 37-year-old man with a pacemaker implanted for complete atrioventricular block who presented with exacerbation of advanced heart failure due to complete extrusion of the pacemaker from the left groin and pacing failure. No fever was observed during the clinical course, but exudate leaked from his abdominal pocket. Electrocardiography showed a complete atrioventricular block. He successfully underwent implantation of a new pacemaker.
LEARNING OBJECTIVE
There are various complications related to permanent pacemaker implantation; however, total extrusion, which is extremely rare, can lead to pacemaker failure, sepsis, and life-threatening arrhythmias. It is essential not only to check the pacemaker pocket and generator but also to educate patients on the importance of pacemaker check-ups and problems.
PubMed: 35949569
DOI: 10.1016/j.jccase.2022.04.002 -
Cureus Feb 2022Introduction Implantation of cardiac implantable electronic devices (CIEDs) is an art of science. As the volume of implantation has increased worldwide, so has the rate...
Introduction Implantation of cardiac implantable electronic devices (CIEDs) is an art of science. As the volume of implantation has increased worldwide, so has the rate of complications. Infection, fibrosis, lead and device erosion, lead displacement, right ventricle perforation, lead fracture, and insulation break are the common complications in the implantation process. This exposes the patient for reopening and threatens the implantation for further complication due to infection, fibrosis of veins, failure to retrieve the implanted wire, and failure to re-implant the device on the same site. We slightly changed our implantation technique to preserve the implantation site for future implantation and reduce the rate of complication in the index implantation. Methods This randomized control trial was conducted from January 2016 to September 2019 at Hayatabad Medical Complex Peshawar, Pakistan. A consecutive sampling technique was used to obtain a sample size of 602 patients keeping a 95% confidence interval and a 5% margin error. We adopted a strategy to take prick, for implantation of devices, inside the pocket, which reduces the number of sutures, hastens the procedure, prevents erosion, and minimizes the chance of subclavian crush syndrome and insulation break. We also selected the minimum possible length of leads. This will possibly decrease the chances of cumbersome fibrosis around the lead and device and will make future implantation convenient. Results There was a total of 602 procedures in the study period. About 253 (42%) procedures were done in the newly adopted strategy and 349 (58%) were performed in the conventional way. Our complication rate grossly reduces in the novel way of implantation in which we took our prick inside the pocket. Conclusion A slight modification in the implantation of CIEDs not only prevents the rate of complication in the index implantation but will also possibly preserve the site for future implantation.
PubMed: 35350505
DOI: 10.7759/cureus.22259 -
Indian Pacing and Electrophysiology... 2020Insertable cardiac monitors (ICMs) are often used for long-term monitoring of cardiac rhythm. The Medtronic's LINQ Reveal ™ is a new generation wireless, automated,...
BACKGROUND
Insertable cardiac monitors (ICMs) are often used for long-term monitoring of cardiac rhythm. The Medtronic's LINQ Reveal ™ is a new generation wireless, automated, and patient responsive subcutaneous ECG monitoring device. Despite several advantages to its small size we have noted an unusually high incidence of extrusion at our center.
METHODS
& Results: We conducted a retrospective case analysis to review Reveal LINQs implanted at our center. All devices were inserted using the provided insertion tools. Patients with extruded devices were identified and details regarding the site and technique of insertion, incision closure, use of peri-operative antibiotics, and follow-up details were collected. 81 patients underwent 85 Reveal LINQ implants at a tertiary care University Hospital referral center. The most common reason for implant was suspected arrhythmia with or without structural heart disease or unexplained syncope. There were 4 spontaneous extrusions occurring within 7-24 days after insertion with an incidence rate of 4.7%. One extruded device was anchored to subcutaneous tissue, and no pocket/device infections or hematomas were noted.
CONCLUSIONS
Device migration and erosion through skin are important potential adverse events for the Reveal LINQ implantable loop recorder. This study reports an unexpectedly high rate of extrusion without infection. The authors suggest that the depth of the incision is the main factor impacting extrusions. Larger studies are recommended, however, and a proposed measure to avoid spontaneous extrusion is the design of a longer manufacturer's blade in order to increase the depth of the incision and insertion.
PubMed: 32298763
DOI: 10.1016/j.ipej.2020.04.005 -
Indian Journal of Otolaryngology and... Dec 2019The tympanic membrane retraction pocket is a pathological invagination of tympanic membrane into the middle ear space. The most common sites for formation of retraction...
The tympanic membrane retraction pocket is a pathological invagination of tympanic membrane into the middle ear space. The most common sites for formation of retraction pocket are pars flaccida and postero-superior parts. Decision about the procedure and the timing of the treatment of retraction pockets is debatable and depends on the functional and anatomic condition of the ear. To evaluate the results of the technique of two handed endoscopic management of retraction pockets with sliced tragal cartilage. Prospective Non Randomized Clinical Study. The study included 41 ears operated with the technique of two handed endoscopic cartilage tympanoplasty for retraction pockets with endoscope holders from November 2013 to May 2016 with a follow up period ranging from 22 to 53 months. Cases of cholesteatoma and tympanic membrane perforation were excluded from the study. Pre and postoperative symptoms and air-bone gaps were recorded. The average preoperative air-bone gap in the study group was 24.53 ± 4.326 dB. 28 ears were of pars tensa retractions (stage II-4, stage III-15, and stage IV-9) and 13 were pars flaccida retractions (stage III-8 and stage IV-5). 24 ears had ossicular erosion. The follow up revealed that, the results of two handed endoscopic sliced cartilage tympanoplasty for retraction pockets were stable and there was no recurrence of the retraction and the post-operative air-bone-gap closure was achieved to 13.62 ± 4.78, 14.13 ± 5.91 dB, 14.32 ± 3.46 and 14.57 ± 3.88 dB at 6 months, 1 year, 2 years, 3 years respectively. Though, indications for surgery are based mostly on anatomic status and observation of behaviour of retraction pocket over time, we recommend early management of retraction pockets by the technique of endoscopic sliced tragal cartilage tympanoplasty with tragal cartilage of 0.5 mm thickness using endoscope holder. : Level 4.
PubMed: 31750111
DOI: 10.1007/s12070-019-01682-2