Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections.

BACKGROUND: Present guidelines endorse complete removal of cardiovascular implantable electronic devices (pacemakers/defibrillators), including extraction of all intracardiac electrodes, not only for systemic infections, but also for localized pocket infections. OBJECTIVES: The authors evaluated the efficacy of delivering continuous, in situ-targeted, ultrahigh concentration of antibiotics (CITA) into the infected subcutaneous device pocket, obviating the need for device/lead extraction. METHODS: The CITA group consisted of 80 patients with pocket infection who were treated with CITA during 2007-2021. Of them, 9 patients declined lead extraction because of prohibitive operative risk, and 6 patients had questionable indications for extraction. The remaining 65 patients with pocket infection, who were eligible for extraction, but opted for CITA treatment, were compared with 81 patients with pocket infection and similar characteristics who underwent device/lead extraction as primary therapy. RESULTS: A total of 80 patients with pocket infection were treated with CITA during 2007-2021. CITA was curative in 85% (n = 68 of 80) of patients, who remained free of infection (median follow-up 3 years [IQR: 1.0-6.8 years]). In the case-control study of CITA vs device/lead extraction, cure rates were higher after device/lead extraction than after CITA (96.2% [n = 78 of 81] vs 84.6% [n = 55 of 65]; P = 0.027). However, rates of serious complications were also higher after extraction (n = 12 [14.8%] vs n = 1 [1.5%]; P = 0.005). All-cause 1-month and 1-year mortality were similar for CITA and device/lead extraction (0.0% vs 3.7%; P = 0.25 and 12.3% vs 13.6%; P = 1.00, respectively). Extraction was avoided in 90.8% (n = 59 of 65) of extraction-eligible patients treated with CITA. CONCLUSIONS: CITA is a safe and effective alternative for patients with pocket infection who are unsuitable or unwilling to undergo extraction. (Salvage of Infected Cardiovascular Implantable Electronic Devices [CIED] by Localized High-Dose Antibiotics; NCT01770067).

Reckless administration of QT interval-prolonging agents in elderly patients with drug-induced torsade de pointes.

A systematic review was conducted for all published case reports on drug-induced torsade de pointes (TdP) in elderly (≥80 years) patients to study if the administration of the offending agent was reckless. Overall, 61 reports on drug-induced TdP in patients aged 80-97 years were included in the analysis. Non-modifiable risk factors for drug-induced TdP (e.g. acute coronary syndrome, female gender and congestive heart failure), modifiable risk factors (e.g. hypokalemia, severe hypomagnesemia and digitalis toxicity) and reckless administration of a QT interval-prolonging agent (e.g. despite a known QT interval prolongation or a history of TdP, together with other QT interval prolonging agents in higher than recommended doses) were recorded in each case. Overall, 54 (88.5%) patients had non-modifiable risk factors for drug-induced TdP and 21 (34.4%) patients had modifiable risk factors. The administration of the offending agent was reckless in one half (n = 31; 50.8%) of the patients. The most prevalent reckless administration of a QT interval-prolonging agent was together with other QT interval-prolonging agents (n = 16; 51.6%) or despite QT interval prolongation (n = 8; 25.8%). In conclusion, although risk factors for drug-induced TdP are prevalent in elderly patients with drug-induced TdP, in approximately 50% of patients it appeared following a reckless administration of a QT interval-prolonging agent. In this population physicians should particularly avoid administration of two or more QT interval-prolonging agents simultaneously or administration of a QT interval-prolonging agent despite QT interval prolongation.

Elective Neck Dissection vs Observation in Early-Stage Squamous Cell Carcinoma of the Oral Tongue With No Clinically Apparent Lymph Node Metastasis in the Neck: A Systematic Review and Meta-analysis.

IMPORTANCE: The elective management of no clinical or radiologic evidence of lymph node metastasis in the neck (cN0) in early stage T1-T2 oral tongue squamous cell carcinoma (OTSCC) has been the subject of much debate during the past 3 decades and continues to be controversial. OBJECTIVE: To systematically review the literature and carry out a meta-analysis of studies that compared elective neck dissection (END) with observation in patients with early-stage T1-T2 OTSCC and cN0 neck. DATA SOURCES: The MEDLINE, Scopus, Google scholar, and Cochrane databases were systematically searched for articles published between January 1, 1970, and June 1, 2015. Search terms used were squamous cell carcinoma, oral tongue, mobile tongue, T1, T2, early stage, elective neck dissection, no neck treatment, observation, wait and watch, node-negative neck, and N0 neck. STUDY SELECTION: Controlled clinical trials, prospective and retrospective cohorts, case-control studies, and case series that compared END with observation in patients with early-stage T1-T2 OTSCC who had no clinical or radiologic evidence of lymph node metastasis to the neck were eligible for inclusion in this meta-analysis. All patients included had a histopathologic diagnosis of SCC and at least 6 months of follow-up. Regional (neck) nodal recurrence, overall survival (OS), and disease-specific survival (DSS) were tested. DATA EXTRACTION AND SYNTHESIS: Four researchers independently extracted information on population characteristics, outcomes of interest, and study design. Discrepancies were resolved by consensus. Fixed effects were used to determine hazard ratios (HRs) and odds ratio (ORs) were used for studies including samples without substantial heterogeneity; random effects were evaluated for samples with significant heterogeneity. RESULTS: A total of 20 retrospective and 3 prospective randomized studies that met the inclusion criteria, with a total of 3244 patients, were included in the meta-analysis The results showed that END significantly reduced risk of regional recurrence (random-effects model: OR, 0.32; 95% CI, 0.22-0.46; P < .001) and improved DSS (fixed-effects model: HR, 0.49; 95% CI, 0.33-0.72; P < .001) compared with management by observation. However, END did not significantly improve OS (random-effects model: HR, 0.71; 95% CI, 0.41-1.22; P = .21). CONCLUSIONS AND RELEVANCE: The findings of this systematic review and meta-analysis indicate that END can significantly reduce the rate of regional nodal recurrence and improve DSS in patients with cT1T2N0 OTSCC.

Impact of preoperative embolization on the outcomes of carotid body tumor surgery: A meta-analysis and review of the literature.

BACKGROUND: There is no consensus on the impact of preoperative embolization (EMB) on the surgical outcomes of carotid body tumor (CBT) resections. METHODS: A systematic review and a meta-analysis were conducted to clarify the role of preoperative EMB in patients undergoing surgical removal of CBTs. RESULTS: Fifteen studies with a total number of 470 patients met the inclusion criteria. The results of the meta-analysis showed that there is no significant difference in estimated blood loss, operative time, length of hospital stay, or risks of cranial nerve injury, vascular injury, and stroke between the EMB and nonembolization (NEMB) groups. CONCLUSION: This systemic review and meta-analysis demonstrate that preoperative EMB does not confer any operative or postoperative advantage in patients scheduled for CBT surgery. © 2016 Wiley Periodicals, Inc. Head Neck 38: E2386-E2394, 2016.

Predictive factors for perioperative blood transfusion in neck dissection.

OBJECTIVES/HYPOTHESIS: There is growing interest in reducing the exposure of patients to allogeneic blood transfusions by lowering preoperative cross-matched blood ordering and adopting alternative practices, such as autologous blood donations. Our aim was to investigate the predictors for perioperative blood transfusion (PBT) in head and neck cancer patients undergoing neck dissection (ND). STUDY DESIGN: Retrospective cohort study. METHODS: Retrospective observational study. All patients who underwent ND between January 2011 and August 2014. The primary outcome measure was PBT. Predictors tested included: gender, age, American Society of Anesthesiologists comorbidity score, Charlson comorbidity index, preoperative hemoglobin level, head and neck primary tumor location, tumor and nodal staging, side and laterality of ND, central versus lateral ND, elective ND, preoperative chemotherapy/radiotherapy/I(131) therapy, history of previous ND, other surgical procedures in addition to the ND, bone resection, use and type of reconstruction, and the use of bony free flap reconstruction. RESULTS: Twenty-one preoperative and operative variables were tested for an association with PBT using univariate and multivariate analyses. Multivariate analysis found only the following three predictors to be significantly associated with PBT in patients undergoing ND: low preoperative hemoglobin level, advanced N stage, and concurrent reconstructive surgery. CONCLUSION: Evaluation of specific risk factors for predicting the need for PBT prior to neck dissection may be helpful in identifying the head and neck cancer patients in whom preoperative ordering of cross-matched blood is required or who could benefit from alternative means, such as preoperative autologous blood donation. LEVEL OF EVIDENCE: 4.

Revision endoscopic stapler Zenker's diverticulotomy.

BACKGROUND: Endoscopic stapler diverticulotomy (ESD) has become an accepted primary treatment for Zenker's diverticulum (ZD). Recurrence of symptoms after surgical treatment of ZD is not uncommon, and traditionally patients with recurrent symptomatic ZD were referred to revision surgery by the transcervical Zenker's diverticulectomy approach. Our objective was to evaluate the technical feasibility, safety and effectiveness of revision endoscopic stapler diverticulotomy (RESD) for recurrent ZD. METHODS: A case series with chart review study conducted in a tertiary referral center. The records of all patients who underwent ESD at our institute between 2002 and 2013 were retrieved and those who underwent RESD were identified and screened for primary surgical history, symptoms of recurrent ZD, time to recurrence, intraoperative and postoperative RESD course, complications and symptom resolution. The surgical history and outcome results of RESD and primary ESD (PESD) patients were compared. RESULTS: Eighty-nine ESDs were performed. Twenty were RESDs for recurrent ZD, and 69 were PESDs. Nine RESDs were performed for recurrent ZD after transcervical Zenker's diverticulectomy, 10 RESDs for recurrent ZD after ESD, and one initial surgical approach was unknown. The mean time from first operation for ZD to RESD was 4.7 years. The average RESD surgery time and hospital stay were 21.4 min and 2.8 days, respectively. Endoscopic stapling of the ZD was feasible in 19 of 20 RESDs. Relief of symptoms without recurrence was achieved after 18 RESDs. Four RESD patients experienced minor postoperative complications. There were no significant differences in operative time, technical feasibility, hospital stay and complication rate between the RESD and PESD groups (P > .05). CONCLUSION: RESD for ZD is technically feasible, safe and effective. The results are comparable to those of PESD.

One stage combined endoscopic and per-oral buccal fat pad approach for large oro-antral-fistula closure with secondary chronic maxillary sinusitis.

There are numerous surgical approaches for oro-antral-fistula (OAF) closure. Secondary sinus disease is still considered by many experts a relative contra indication for primary closure. To describe a single-stage combined endoscopic sinus surgery and per-oral buccal fat pad (BFP) flap approach for large OAF causing chronic maxillary sinusitis. The records of all the patients with OAF and chronic manifestations of secondary rhinosinusitis that were treated between 2010 and 2013 in our tertiary care medical center were reviewed. The exclusion criteria were: OAF ≤ 5 mm, resolved sino-nasal disease, OAF secondary to malignancy, recurrent fistula, medical history that included radiotherapy to the maxillary bone and age <18 years. Each procedure was performed by a team consisting of a rhinologist and a maxillofacial surgeon. The surgical approach included an endoscopic middle antrostomy with maxillary sinus drainage, and a per-oral BFP regional flap for OAF closure. Total OAF closure, complications and need for revision surgeries. Forty-five patients that underwent OAF closure together with sinus surgery using a combined endoscopic sinus surgery (ESS) and BFP flap approach met the inclusion criteria. There were 28 males and 17 females with a mean ± SD age of 53.5 ± 14.9 years (range 22-80 years). The presenting signs and symptoms included purulent rhinorrhea (n = 22, 48.9 %), foreign body in sinus (n = 10, 22.2 %) nasal congestion (n = 7, 15.5 %), halitosis (n = 6, 13.3 %) and pain (n = 5, 12.2 %). Surgical complications included local pain (n = 2, 4.4 %), persistent rhinitis (n = 2, 4.4 %) and synechia (n = 1, 2.2 %). One patient required revision surgery due to an unresolved OAF. The OAF of all the other 44 patients (97.8 %) was closed after the first procedure and the paranasal sinuses on the treated side were completely recovered. The mean follow-up time for the group was 7.6 ± 4.3 months (7-21 months), and no untoward sequelae or recurrence were reported. Combined, one step, endoscopic Maxillary sinus drainage together with per-oral BFP flap approach is an efficacious surgical approach for safe closure of OAFs that are complicated with secondary chronic maxillary sinusitis.

Intraoperative pulmonary function dynamics in adolescents undergoing reduction mammoplasty: A prospective case series.

BACKGROUND: Improvement of lung function following reduction mammoplasty has been previously reported among adult populations in the medical literature. OBJECTIVES: To evaluate the intraoperative dynamics of pulmonary function in adolescents undergoing reduction mammoplasty. METHODS: The present study is a prospective case series of female patients 13 to 18 years of age who underwent inferior pedicle reduction mammoplasty between November 20, 2006 and April 4, 2011. Documented variables included patient baseline characteristics, operation duration, muscle relaxant use and total breast tissue removed. Intraoperative pulmonary function data documented included: tidal volume, respiratory rate, peak inspiratory pressure, positive end-expiratory pressure, oxygen saturation percentage and pulmonary compliance. Differences in pulmonary function data were calculated as ratio between final and initial intraoperative values. RESULTS: Twenty-six patients were included in the analysis. Mean (± SD) age was 16.9±1.1 years and mean body mass index was 28.9±6.1 kg/m(2). Mean operation time was 218±52 min, with average total bilateral breast tissue removal of 1810±1065 g. Improvement in lung compliance was observed in 24 patients (92.3%; P<0.0001). Mean intraoperative lung compliance improvement was 23.92% (95% CI 8.3% to 37%; P=0.001). CONCLUSION: Intraoperative improvement in lung compliance was observed in adolescent patients undergoing reduction mammoplasty.

HISTORIQUE: Les publications médicales ont déjà fait état d'une amélioration de la fonction pulmonaire au sein de la population adulte après une mammoplastie de réduction. OBJECTIFS: Évaluer la dynamique peropératoire de la fonction pulmonaire chez des adolescentes qui subissent une mammoplastie de réduction. MÉTHODOLOGIE: Les chercheurs ont étudié la présente série de cas prospectifs de patientes de 13 à 18 ans qui ont subi une mammoplastie de réduction du pédicule inférieur entre le 20 novembre 2006 et le 4 avril 2011. Les variables observées incluaient les caractéristiques initiales des patientes, la durée de l'opération, l'utilisation de relaxants musculaires et la quantité totale de tissus mammaires extraits. Les données sur la fonction pulmonaire peropératoire observées incluaient le volume respiratoire, la fréquence respiratoire, la pression inspiratoire de pointe, la pression positive en fin d'expiration, le pourcentage de saturation en oxygène et la compliance pulmonaire. Les chercheurs ont calculé les différences dans les données sur la fonction pulmonaire entre les valeurs peropératoires finales et initiales. RÉSULTATS: Vingt-six patientes ont participé à l'analyse. Elles avaient un âge moyen (± ÉT) de 16,9±1,1 ans et un indice de masse corporelle moyen de 28,9±6,1 kg/m2. La durée moyenne de l'opération était de 218±52 min, et le retrait bilatéral total moyen de tissus, de 1 810±1 065 g. La compliance pulmonaire s'est améliorée chez 24 patientes (92,3 %; P<0,0001). L'amélioration peropératoire moyenne de la compliance pulmonaire s'élevait à 23,92 % (95 % IC 8,3 % à 37 %; P=0,001). CONCLUSION: On observe une amélioration peropératoire de la compliance pulmonaire chez les adolescentes qui subissent une mammoplastie de réduction.

Nasopharyngeal biopsy in adults: a large-scale study in a non endemic area.

BACKGROUND: Limited data exist on the referral criteria for endoscopic-guided nasopharyngeal biopsy to rule out nasopharyngeal malignancy among adults in a non-endemic area. METHODS: Retrospective study of all adult patients that had been referred to our outpatient clinic to undergo endoscopic-guided nasopharyngeal biopsy to exclude nasopharyngeal malignancy between 1/2006-10/2013. All medical consultation referral letters were reviewed, and statistical analyses were conducted to evaluate clinically significant predictors (demographics, clinical manife- stations, nasopharyngeal endoscopic findings) for nasopharyngeal malignancy. RESULTS: A total of 470 patients (470 nasopharyngeal biopsies, 54.9% males and 66% smokers) were included. The most common pathological result was adenoid/lymphoid hyperplasia (76.2%). The overall negative rate of all biopsies for malignancy was 94.2%. Twenty-seven patients had nasopharyngeal malignancy: 22 had squamous cell carcinoma and 5 had non-Hodgkin`s lymphoma. Advanced age, cervical mass, and suspicious nasopharyngeal mass were independent risk factors for nasopharyngeal malignancy on univariate and multivariate analyses. CONCLUSIONS: Nasopharyngeal biopsy may safely be avoided in adults living in a non-endemic area for NPC who are free of the risk factors of advanced age, the presence of a cervical mass, and suspicious nasopharyngeal mass.

Elective neck irradiation versus observation in squamous cell carcinoma of the maxillary sinus with N0 neck: A meta-analysis and review of the literature.

BACKGROUND: Elective neck irradiation of a clinical node-negative (N0) neck in squamous cell carcinoma (SCC) of the maxillary sinus is a controversial issue. METHODS: A systematic review of electronic databases and a meta-analysis were conducted to clarify the role of elective neck irradiation in patients with SCC of the maxillary sinus and clinical N0 neck. Regional (neck) nodal recurrence was chosen as the primary endpoint. RESULTS: Four retrospective studies with a total of 129 patients met the inclusion criteria. The results of the meta-analysis showed that elective neck irradiation reduced the risk of regional nodal recurrence (fixed effects model: odds ratio [OR] = 0.16; 95% confidence interval [CI] = 0.04-0.67; p = .01; random-effects model: OR = 0.17; 95% CI = 0.04-0.76; p = .02) compared to observation. CONCLUSION: This systemic review and first meta-analysis confirmed that elective neck irradiation can significantly reduce the rate of nodal recurrence in patients with N0 SCC of the maxillary sinus.

Stress-relaxation and tension relief system for immediate primary closure of large and huge soft tissue defects: an old-new concept: new concept for direct closure of large defects.

Stress-relaxation is a well-established mechanism for laboratory skin stretching, with limited clinical application in conventional suturing techniques due to the inherent, concomitant induction of ischemia, necrosis and subsequent suture failure. Skin defects that cannot be primarily closed are a common difficulty during reconstructive surgery. The TopClosure tension-relief system (TRS) is a novel device for wound closure closure, providing secured attachment to the skin through a wide area of attachment, in an adjustable manner, enabling primary closure of medium to large skin defects. The aim of this study was to evaluate the efficiency of the TopClosure TRS as a substitute for skin grafting and flaps for primary closure of large soft tissue defects by stress-relaxation. We present three demonstrative cases requiring resection of large to huge tumors customarily requiring closure by skin graft or flaps. TRS was applied during surgery serving as a tension-relief platform for tension sutures, to enable primary skin-defect closure by cycling of stress-relaxation, and following surgery as skin-secure system until complete wound closure. All skin defects ranging from 7 to 26 cm in width were manipulated by the TRS through stress-relaxation, without undermining of skin, enabling primary skin closure and eliminating the need for skin grafts and flaps. Immediate wound closure ranged 26 to 135 min. TRS was applied for 3 to 4 weeks. Complications were minimal and donor site morbidity was eliminated. Surgical time, hospital stay and costs were reduced and wound aesthetics were improved. In this case series we present a novel technology that enables the utilization of the viscoelastic properties of the skin to an extreme level, extending the limits of primary wound closure by the stress-relaxation principle. This is achieved via a simple device application that may aid immediate primary wound closure and downgrade the complexity of surgical procedures for a wide range of applications on a global scale.

A substitute for skin grafts, flaps, or internal tissue expanders in scalp defects following tumor ablative surgery.

BACKGROUND: The skin of the scalp is relatively thick, minimally mobile, with distinct hair distribution. TopClosure® is a novel device for skin stretching and secure wound closure. OBJECTIVES: To evaluate the efficacy of the TopClosure® system in primary closure of moderate and large scalp defects, as a substitute for skin grafts, flaps, and tissue expanders. METHODS: We report a retrospective series of 8 patients requiring resection of 9 scalp tumors resulting with moderate to large size defects that otherwise would have required reconstruction with skin grafts, flaps, or tissue expanders. TopClosure® was applied for intraoperative cycles of stress-relaxation, followed, when indicated, by additional steps of mechanical creep and scar secure. RESULTS: Skin defects, averaging 3.5 cm, were managed by TopClosure®, enabling, primary closure in all wounds. Immediate wound edge approximation was reached through stress-relaxation in 2 wounds by heavy tension sutures within one hour. Further skin stretching by mechanical creep was required in 7 wounds, achieving staged primary closure in an outpatient setting. TopClosure® was further applied to secure the skin for up to 3 weeks following surgery. CONCLUSIONS: The TopClosure system, effectively, aided closure of moderate and large scalp defects by stress-relaxation and mechanical creep and serving as a topical tension-relief platform for tension sutures, allowing mobilization of skin and subcutaneous tissue without undermining or need of drainage, for early, direct wound closure. Local complications were minimal and donor site morbidity was eliminated. Surgical time, hospital stay and costs were reduced, and post-operative wound aesthetics were improved.

The TopClosure® 3S System, for skin stretching and a secure wound closure.

The principle of stretching wound margins for primary wound closure is commonly practiced and used for various skin defects, leading at times to excessive tension and complications during wound closure. Different surgical techniques, skin stretching devices and tissue expanders have been utilized to address this issue. Previously designed skin stretching devices resulted in considerable morbidity. They were invasive by nature and associated with relatively high localized tissue pressure, frequently leading to necrosis, damage and tearing of skin at the wound margins. To assess the clinical effectiveness and performance and, to determine the safety of TopClosure® for gradual, controlled, temporary, noninvasive and invasive applications for skin stretching and secure wound closing, the TopClosure® device was applied to 20 patients for preoperative skin lesion removal and to secure closure of a variety of wound sizes. TopClosure® was reinforced with adhesives, staples and/or surgical sutures, depending on the circumstances of the wound and the surgeon's judgment. TopClosure® was used prior to, during and/or after surgery to reduce tension across wound edges. No significant complications or adverse events were associated with its use. TopClosure® was effectively used for preoperative skin expansion in preparation for dermal resection (e.g., congenital nevi). It aided closure of large wounds involving significant loss of skin and soft tissue by mobilizing skin and subcutaneous tissue, thus avoiding the need for skin grafts or flaps. Following surgery, it was used to secure closure of wounds under tension, thus improving wound aesthetics. A sample case study will be presented. We designed TopClosure®, an innovative device, to modify the currently practiced concept of wound closure by applying minimal stress to the skin, away from damaged wound edges, with flexible force vectors and versatile methods of attachment to the skin, in a noninvasive or invasive manner.