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1.
BMJ Open ; 14(5): e081749, 2024 May 17.
Article in English | MEDLINE | ID: mdl-38760049

ABSTRACT

OBJECTIVES: To compare catheter-related outcomes of individuals who received a tunnelled femorally inserted central catheter (tFICC) with those who received a peripherally inserted central catheter (PICC) in the upper extremities. DESIGN: A propensity-score matched cohort study. SETTING: A 980-bed tertiary referral hospital in South West Sydney, Australia. PARTICIPANTS: In-patients referred to the hospital central venous access service for the insertion of a central venous access device. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome of interest was the incidence of all-cause catheter failure. Secondary outcomes included the rates of catheters removed because of suspected or confirmed catheter-associated infection, catheter dwell and confirmed upper or lower extremity deep vein thrombosis (DVT). RESULTS: The overall rate of all-cause catheter failure in the matched tFICC and PICC cohort was 2.4/1000 catheter days (95% CI 1.1 to 4.4) and 3.0/1000 catheter days (95% CI 2.3 to 3.9), respectively, and when compared, no difference was observed (difference -0.63/1000 catheter days, 95% CI -2.32 to 1.06). We found no differences in catheter dwell (mean difference of 14.2 days, 95% CI -6.6 to 35.0, p=0.910); or in the cumulative probability of failure between the two groups within the first month of dwell (p=0.358). No significant differences were observed in the rate of catheters requiring removal for confirmed central line-associated bloodstream infection (difference 0.13/1000 catheter day, 95% CI -0.36 to 0.63, p=0.896). Similarly, no significant differences were found between the groups for confirmed catheter-related DVT (difference -0.11 per 1000 catheter days, 95% CI -0.26 to 0.04, p=1.00). CONCLUSION: There were no differences in catheter-related outcomes between the matched cohort of tFICC and PICC patients, suggesting that tFICCs are a possible alternative for vascular access when the veins of the upper extremities or thoracic region are not viable for catheterisation.


Subject(s)
Catheter-Related Infections , Catheterization, Central Venous , Catheterization, Peripheral , Propensity Score , Humans , Female , Male , Middle Aged , Catheter-Related Infections/epidemiology , Catheter-Related Infections/etiology , Catheterization, Central Venous/adverse effects , Catheterization, Central Venous/methods , Catheterization, Peripheral/adverse effects , Aged , Central Venous Catheters/adverse effects , Cohort Studies , Australia/epidemiology , Adult , Catheters, Indwelling/adverse effects , Device Removal/statistics & numerical data , Equipment Failure/statistics & numerical data
2.
Isr Med Assoc J ; 26(5): 273-277, 2024 May.
Article in English | MEDLINE | ID: mdl-38736340

ABSTRACT

BACKGROUND: Cardiac implantable electronic devices (CIEDs) are increasingly being used; thus, there is an increasing need for transvenous lead extraction (TLE). OBJECTIVES: To summarize our experience with TLE at single referral center in northern Israel. METHODS: The study included all patients who underwent TLE at our center between 2019 and 2022, regardless of the indication. RESULTS: The cohort included 50 patients. The mean age was 69 ± 10.36 years; 78% were males. A total of 99 electrodes were targeted. The mean number of electrodes was 1.96 (range 1-4) per patient. The time between lead implantation and extraction ranged between 1.1 and 34 years with an average of 8.14 ± 5.71 years (median of 7.5 years). Complete lead removal was achieved in 98% of patients and in 98.99% of leads. The complete procedural success rate as well as the clinical procedural success rate was 96%. The procedural failure rate was 4% (1 patient died 2 days after the index procedure and 1 patient remained with large portion of lead). The indication for TLE was infection in 78% of the cohort group. Powered mechanical sheaths were used in 36 patients (72%), laser sheaths in 27 (54%), and a combination of laser and mechanical sheaths in 16 (32%). CONCLUSIONS: The clinical and procedural success rates of TLE, primarily for CEID-related infection, were high. A combination of laser and mechanical sheaths was needed in one-third of patients.


Subject(s)
Defibrillators, Implantable , Device Removal , Pacemaker, Artificial , Humans , Device Removal/methods , Device Removal/statistics & numerical data , Male , Israel/epidemiology , Female , Aged , Retrospective Studies , Treatment Outcome , Middle Aged , Electrodes, Implanted , Aged, 80 and over
3.
Urogynecology (Phila) ; 30(6): 550-556, 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38373241

ABSTRACT

IMPORTANCE: In-office postoperative voiding trials (VTs) increase health care burden for patients and physicians. Adoption of an at-home VT option may decrease burden without increasing adverse events postoperatively. OBJECTIVE: The purpose of this study was to compare 30-day postoperative outcomes between participants who performed an at-home autofill VT after catheter self-discontinuation during the Assessing Healthcare Utilization and Feasibility of Transurethral Catheter Self-discontinuation (FLOTUS) study and a "historic" control cohort of patients who presented to the office for backfill-assisted VT on postoperative day (POD) 1. STUDY DESIGN: This was a retrospective cohort study of women with postoperative urinary retention after urogynecologic surgery between June 2020 and March 2022. Outcomes from the FLOTUS study were compared with a "historic" control cohort of patients that were identified on chart review from the year before FLOTUS initiation. Demographic, medical history, and procedure-related data were collected. Thirty-day outcome data included office calls/messages, office visits, emergency department visits, complications, and catheterization outcomes. RESULTS: Forty-six participants were included in the FLOTUS cohort and 65 participants in the historic cohort. There was no difference in the POD1 VT pass rate, number of office calls/messages, emergency department visits, or postoperative complications between the 2 cohorts. The FLOTUS patients attended 1 less office visit (1 vs 2 office visits, P <0.001), and this difference persisted on regression analysis (-0.87 office visits; 95% CI, -1.18 to -0.56, P <0.001). CONCLUSION: Patients who had backfill-assisted VTs on POD1 attended 1 additional office visit compared with those who removed their catheters at home.


Subject(s)
Device Removal , Postoperative Complications , Urinary Catheterization , Urinary Retention , Humans , Female , Retrospective Studies , Middle Aged , Aged , Device Removal/statistics & numerical data , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Urinary Retention/etiology , Urinary Retention/epidemiology , Urinary Catheterization/adverse effects , Urinary Catheterization/statistics & numerical data , Gynecologic Surgical Procedures/adverse effects , Urinary Catheters/adverse effects , Self Care
4.
JACC Heart Fail ; 12(5): 893-901, 2024 May.
Article in English | MEDLINE | ID: mdl-38276935

ABSTRACT

BACKGROUND: Myocardial recovery occurs in patients with advanced heart failure on left ventricular assist device (LVAD) support, but there is the premise that it is rare with uncertain results. OBJECTIVES: The goal of this study was to investigate the incidence and consequence of LVAD explant after myocardial recovery. METHODS: Using the United Network for Organ Sharing registry, LVAD implants in the United States between 2005 and 2020 were tracked until death, transplantation, or explant for myocardial recovery. The cohort undergoing explant was followed up for heart failure relapse (defined as relisting followed by delisting due to death, being too ill, or transplantation; or second durable LVAD implant). RESULTS: Of 15,728 LVAD implants, 126 patients underwent explant for recovery, which only occurred in 55 (38%) of 145 implanting centers. The crude cumulative incidence was 0.7% at 2 years, whereas the incidence reached 4.7% among designated centers in the selected young nonischemic cohort. Of 126 explanted patients, 76 (60%) were subsequently delisted for sustained recovery. Heart failure relapsing had a relatively higher hazard in the early phase, with a 30-day incidence of 6% (7 of 126) but tapered following with the freedom rate of 72.5% at 4 years. CONCLUSIONS: In the United States, LVAD explant for myocardial recovery was underutilized, leading to a very low incidence at the national level despite a realistic rate being achieved in designated centers for selected patients. With follow-up extending up to 4 years after explant, more than one-half were successfully removed and stayed off the waitlist, and approximately 70% were free from heart failure relapse events.


Subject(s)
Device Removal , Heart Failure , Heart-Assist Devices , Humans , Heart Failure/epidemiology , Heart Failure/therapy , Heart Failure/physiopathology , Heart Failure/surgery , Male , Female , Middle Aged , Incidence , United States/epidemiology , Device Removal/statistics & numerical data , Adult , Recovery of Function , Registries , Recurrence , Aged , Retrospective Studies
5.
Laryngoscope ; 132(3): 554-559, 2022 03.
Article in English | MEDLINE | ID: mdl-34363218

ABSTRACT

OBJECTIVE: Investigate current practice patterns of head and neck microvascular reconstructive surgeons when removing an implantable Doppler after free flap surgery. STUDY DESIGN: Cross-sectional survey study. METHODS: Survey distributed to head and neck microvascular reconstructive surgeons. Data regarding years performing free tissue transfer, case numbers, management of implantable Doppler wire, and complications were collected. RESULTS: Eighty-five responses were analyzed (38,000 cases). Sixty-six responders (77.6%) use an implantable Doppler for postoperative monitoring, with 97% using the Cook-Swartz Doppler Flow Monitoring System. Among this group, 65.2% pull the wire after monitoring was complete, 3% cut the wire, and 31.8% have both cut and pulled the wire. Of those who have cut and pulled the wire, 48% report cutting and pulling the wire with equal frequency, 43% formerly pulled the wire and now cut the wire, and 9% previously cut the wire but now pull the wire. Of those who pull the wire, there were two injuries to the pedicle requiring return to the operating for flap salvage, and one acute venous congestion. Of the nine who previously pulled the wire, six (67%) cited concerns with major bleeding/flap compromise as the reason for cutting the wire. CONCLUSION: In this study, most surgeons use an implantable Doppler for monitoring of free flaps postoperatively. In extremely rare instances, pulling the implantable Doppler wire has resulted in flap compromise necessitating revision of the vascular anastomosis. Cutting the wire and leaving the proximal portion in the surgical site has been adopted as a management option. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:554-559, 2022.


Subject(s)
Device Removal/statistics & numerical data , Free Tissue Flaps/blood supply , Laser-Doppler Flowmetry/methods , Microcirculation , Otorhinolaryngologic Surgical Procedures/methods , Plastic Surgery Procedures/statistics & numerical data , Postoperative Care/methods , Practice Patterns, Physicians'/statistics & numerical data , Cross-Sectional Studies , Device Removal/methods , Free Tissue Flaps/surgery , Humans , Laser-Doppler Flowmetry/instrumentation , Otorhinolaryngologic Surgical Procedures/instrumentation , Otorhinolaryngologic Surgical Procedures/statistics & numerical data , Postoperative Care/instrumentation , Plastic Surgery Procedures/methods , Surveys and Questionnaires , Vascular Patency
6.
Am Surg ; 88(3): 434-438, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34734555

ABSTRACT

BACKGROUND: The morbidity and mortality rates associated with cholecystectomy for acute cholecystitis are higher in the critically ill elderly population. As an alternative to cholecystectomy, we report the results of treatment of acute cholecystitis in the elderly after open cholecystolithotomy with cholecystostomy tube placement under local anesthesia. METHODS: A case series was performed on 5 patients from August 2007 to April 2010 who presented with acute cholecystitis and underwent an open cholecystolithotomy and tube placement. Thirty-day mortality, intra- and immediate-postoperative complications, clinical improvement after drainage, additional biliary procedures needed, and outcome after cholecystostomy tube removal were recorded. RESULTS: Open cholecystolithotomy and tube placement were performed successfully in all patients and permitted resolution of the acute attack in all after a mean period of 3.75 days. Thirty-day mortality was 0%. Patients did not experience any intraoperative complications. We observed 100% rate of successful short-term outcomes in our patients including resolution pain, and objectively, normalization of leukocytosis, and defervescence. None of the patients required emergency cholecystectomy. All patients had their cholecystostomy tubes removed at a mean postoperative day 27. There were no cases of biliary leakage or tube dislodgement. There were no recurrences of acute cholecystitis within the mean follow-up of 20.75 months. DISCUSSION: Emergency open cholecystolithotomy and cholecystostomy tube placement represent an effective, safe, and definitive alternative treatment strategy for acute gallstone cholecystitis in selected elderly patients with a mortality rate of 0% in the authors' experience.


Subject(s)
Anesthesia, Local , Cholecystitis, Acute/surgery , Cholecystostomy/methods , Gallstones/surgery , Aged, 80 and over , Cholecystitis, Acute/etiology , Cholecystitis, Acute/mortality , Cholecystostomy/instrumentation , Cholecystostomy/mortality , Critical Illness , Device Removal/statistics & numerical data , Drainage , Emergencies , Gallstones/complications , Humans , Postoperative Complications/epidemiology , Risk , Time Factors , Treatment Outcome
7.
Isr Med Assoc J ; 23(11): 735-739, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34811991

ABSTRACT

BACKGROUND: Breast implant illness (BII) is a rising concern among many patients. Although not fully understood, a connection between silicone breast implants and systemic diseases may be present. This connection may influence the types of breast surgeries performed. OBJECTIVES: To evaluate changing trends in breast surgeries in Israel over time, with regard to implantation, explantation, and implant exchange surgeries. METHODS: In this ecological study, we presented data from four private medical centers in Israel regarding the number of breast implant surgeries performed in the years 2018-2019. Data were collected bi-yearly. The types of surgeries included breast implantation, explantation, and breast implant exchange. RESULTS: When we summed and compared the yearly data, we saw that the number of implantations in 2018 was 2267 (80.1% of breast implant procedures that year), and 1929 (68.9%) in 2019. The number of implant exchanges in 2018 and 2019 was 482 (17.0%) and 608 (21.7%), respectively. In 2018, 80 (2.8%) explantations were performed and 262 (9.4%) in 2019. CONCLUSIONS: There appears to be a trend in the rise of implant removal surgeries in addition to a decrease in breast implantations. One possible reason may be patient concerns of BII. Another reason may be the increased public interest and discussion about systemic effects of breast implants. More research is needed in this field to achieve better understanding of the phenomenon, the reasons behind it, and the possible solutions and ways of treatment.


Subject(s)
Autoimmune Diseases , Breast Implantation , Breast Implants , Device Removal , Postoperative Complications , Reoperation , Silicone Gels/adverse effects , Autoimmune Diseases/diagnosis , Autoimmune Diseases/etiology , Breast Implantation/adverse effects , Breast Implantation/instrumentation , Breast Implantation/methods , Breast Implantation/statistics & numerical data , Breast Implants/adverse effects , Breast Implants/classification , Breast Implants/trends , Device Removal/methods , Device Removal/statistics & numerical data , Equipment Failure Analysis , Female , Humans , Inflammation/diagnosis , Inflammation/etiology , Israel/epidemiology , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prosthesis Failure , Reoperation/methods , Reoperation/statistics & numerical data
8.
Plast Reconstr Surg ; 148(5): 939-947, 2021 Nov 01.
Article in English | MEDLINE | ID: mdl-34495913

ABSTRACT

BACKGROUND: Breast augmentation is the most common aesthetic operation performed in the United States and worldwide; 1,862,506 breast augmentation procedures were performed in 2018, an increase of 27.6 percent compared to 2014 data. METHODS: In the present study, the authors performed a systematic review to identify the accuracy of ultrasonography for diagnosing breast prosthesis rupture. Studies in which the ultrasound diagnostic test was compared to a surgical finding as a reference standard were reviewed. RESULTS: As a result, 20 primary studies were included in the analyses, with a total of 1987 patients and 3297 prostheses. The use of ultrasound for diagnosis of breast prosthesis rupture presented the following results: pooled sensitivity, 73.7 percent (95 percent CI, 70.2 to 77.1 percent); pooled specificity, 87.8 percent (95 percent CI, 86.5 to 89.0); area under the receiver operating characteristic curve, 0.7762; diagnostic odds ratio, 11.04 (95 percent CI, 5.79 to 21.08). CONCLUSION: This study supports that ultrasound of breast prostheses is an adequate tool in the diagnosis of rupture.


Subject(s)
Breast Diseases/diagnosis , Breast Implantation/adverse effects , Breast Implants/adverse effects , Breast/diagnostic imaging , Prosthesis Failure , Breast Diseases/etiology , Breast Diseases/surgery , Breast Implantation/instrumentation , Device Removal/statistics & numerical data , Female , Humans , ROC Curve , Ultrasonography/statistics & numerical data
9.
World J Urol ; 39(12): 4449-4457, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34272596

ABSTRACT

PURPOSE: To compare transcorporal vs bulbar artificial urinary sphincter (AUS) implantation in men with fragile urethra and to investigate the risk factors of AUS explantation in this population. METHODS: The charts of all male patients who had an AUS implantation between 2004 and 2020 in 16 centers were reviewed retrospectively. The primary endpoint was device explantation-free survival. Only patients with a fragile urethra were included in the present analysis. Fragile urethra was defined as a urethra carrying a high risk of cuff erosion because of prior radiotherapy and/or history of AUS explantation and/or history of urethral stricture surgery. The patients were divided in two groups according to the implantation site: bulbar vs transcorporal. RESULTS: 464 patients were included for analysis. 88 patients underwent a transcorporal AUS implantation and 376 underwent a bulbar AUS implantation. Explantation-free survival was similar in both groups (estimated 5-year explantation free survival rates 55.3% vs. 58.4%; p=0.98). In the subgroup of patients with a history of previous AUS explantation, transcorporal approach tended to bring longer explantation-free survival (2-year explantation-free survival: 61.9% vs. 58.2%; p=0.096). In multivariate analysis, the only risk factor of shorter explantation-free survival was the history of previous AUS explantation (HR=2.65; p=0.01). CONCLUSIONS: Transcorporal AUS implantation was not associated with longer explantation-free survival. History of previous AUS explantation was the only risk factor associated with shorter explantation-free survival and this subgroup of patients may be the only one to draw benefits of transcorporal AUS implantation.


Subject(s)
Prosthesis Implantation/methods , Urinary Sphincter, Artificial , Aged , Aged, 80 and over , Device Removal/statistics & numerical data , Humans , Male , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors
12.
Am J Otolaryngol ; 42(6): 103102, 2021.
Article in English | MEDLINE | ID: mdl-34120008

ABSTRACT

BACKGROUND: Tracheostomy is one of the most common surgical procedures performed on ventilated COVID-19 patients, yet the appropriate timing for operating is controversial. OBJECTIVES: Assessing the effect of early tracheostomy on mortality and decannulation; elucidating changes in ventilation parameters, vasopressors and sedatives dosages immediately following the procedure. METHODS: A retrospective cohort of 38 ventilated COVID-19 patients, 19 of them (50%) underwent tracheostomy within 7 days of intubation (early tracheostomy group) and the rest underwent tracheostomy after 8 days or more (late tracheostomy group). RESULTS: Decannulation rates were significantly higher while mortality rates were non-significantly lower in the early tracheostomy group compared with the late tracheostomy group (58% vs 21% p < 0.05; 42% vs 74% p = 0.1, respectively). Tidal volume increased (446 ml vs 483 ml; p = 0.02) while PEEP (13 cmH20 vs 11.6 cmH2O, p = 0.04) decreased at the immediate time following the procedure. No staff member participating in the procedures was infected with SARS-CoV-2 virus. CONCLUSION: Early tracheostomy might offer improved outcomes with higher decannulation rates and lower mortality rates in ventilated COVID-19 patients, yet larger scale studies are needed. Most likely, early exposure to COVID-19 patients with appropriate personal protective equipment during open tracheostomy does not put the surgical team at risk.


Subject(s)
COVID-19/surgery , Respiration, Artificial , Tracheostomy/methods , Aged , COVID-19/mortality , COVID-19/physiopathology , COVID-19/therapy , Device Removal/statistics & numerical data , Female , Humans , Intubation, Intratracheal/statistics & numerical data , Male , Middle Aged , Retrospective Studies , Tidal Volume , Time Factors , Tracheostomy/statistics & numerical data
13.
J Urol ; 206(5): 1248-1257, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34184925

ABSTRACT

PURPOSE: The main objective of this study was to assess the prevalence and risk factors of male artificial urinary sphincter (AUS) mechanical failures and nonmechanical failures. MATERIALS AND METHODS: The charts of all male patients who underwent AUS implantation between 2004 and 2020 in 16 centers were retrospectively reviewed. Patients with neurogenic stress urinary incontinence (SUI) were excluded as well as revisions/explantations due to infections and/or erosions. The causes of revision were divided into mechanical failures (fluid loss or malfunction from any components of the AUS), nonmechanical failures (urethral atrophy, recurrence/persistence of SUI despite normally functioning device) and other (pump malposition, balloon herniation, hematoma, pain). Failure-free survival analysis was performed both for general and specific causes of revision. Predictors of mechanical and nonmechanical failures were determined by Cox proportional hazards model. RESULTS: A total of 1,020 patients met the inclusion criteria. After a median followup of 20 months, the estimated 5-year and 10-year overall revision-free survival was 60% and 40%, respectively. There were 214 AUS revisions: 59 (27.6%) for mechanical failures, 121 (56.5%) for nonmechanical failures and 34 (15.9%) other causes of revision. In multivariable Cox regression analysis, larger cuff size was the only predictor of overall revisions (HR=1.04 [1.01-1.07]; p=0.01) and revision for nonmechanical failure (HR=1.05 [1.02-1.09]; p=0.004). CONCLUSIONS: Half of the male AUS patients underwent device revision within the first 10 years after implantation. Nonmechanical failures are the primary cause of AUS revision in nonneurological men. Larger cuff size appears to be the main determinant of AUS revision risk.


Subject(s)
Device Removal/statistics & numerical data , Prosthesis Failure , Prosthesis Implantation/adverse effects , Urinary Incontinence/surgery , Urinary Sphincter, Artificial/adverse effects , Aged , Follow-Up Studies , Humans , Male , Prevalence , Prosthesis Implantation/instrumentation , Retrospective Studies , Risk Assessment/statistics & numerical data , Risk Factors , Urinary Incontinence/etiology , Urinary Sphincter, Artificial/statistics & numerical data
14.
Sci Rep ; 11(1): 10337, 2021 05 14.
Article in English | MEDLINE | ID: mdl-33990648

ABSTRACT

Although many ureteral stents are commercially available, the actuality of encrustation is yet to be elucidated in humans. This study compared the Tria Ureteral Stent with PercuShield and the Polaris Ultra Ureteral Stent with HydroPlus Coating for short-term encrustation formation. Eighty-four patients, who required ureteral stent placement after ureteroscopy, were randomized into two stent groups. After stent removal on postoperative day 14, the encrustation volume on the stent surface was measured by micro-computed tomography. The primary outcome was the inner luminal encrustation volume. Secondary outcomes were encrustation volume on the outer or total surfaces and occurrence of adverse events. Clinical factors related to encrustation were also assessed as a post-hoc analysis. Finally, of the 82 patients analyzed, 75 (91.5%) had encrustation in the inner lumen of the stent. The difference in median inner encrustation volume between the Tria and Polaris Ultra stents was comparable (0.56 vs. 0.37 mm3, P = 0.183). There was no difference observed in the encrustation volume on the outer/total surfaces and stent-related adverse events. In both ureteral stents, the shaft body showed significant inner luminal encrustation compared to the proximal or distal loop (all, P < 0.05). Dyslipidemia (P = 0.027), elevated urine pH (P = 0.046), and crystalluria (P = 0.010) were associated with encrustation formation. The Tria and Polaris Ultra stents had similar efficacy for preventing encrustation in the short-term. Further studies are required to compare their long-term patency.


Subject(s)
Stents/adverse effects , Ureteroscopy/instrumentation , Urolithiasis/surgery , Aged , Device Removal/statistics & numerical data , Female , Humans , Male , Middle Aged , Prospective Studies , Stents/statistics & numerical data , Ureter/surgery , Ureteroscopy/adverse effects , X-Ray Microtomography/statistics & numerical data
15.
Plast Reconstr Surg ; 147(3): 556-566, 2021 03 01.
Article in English | MEDLINE | ID: mdl-33620918

ABSTRACT

BACKGROUND: Mentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years. METHODS: This prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure. RESULTS: Primary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent. CONCLUSION: The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.


Subject(s)
Breast Implantation/instrumentation , Breast Implants/adverse effects , Patient Safety/statistics & numerical data , Postoperative Complications/etiology , Prosthesis Failure , Reoperation/statistics & numerical data , Adolescent , Adult , Aged , Breast Implantation/methods , Device Removal/statistics & numerical data , Female , Follow-Up Studies , Humans , Incidence , Kaplan-Meier Estimate , Middle Aged , Outcome Assessment, Health Care , Postoperative Complications/epidemiology , Postoperative Complications/therapy , Prospective Studies , United States , Young Adult
16.
J Am Coll Surg ; 232(6): 872-880.e2, 2021 06.
Article in English | MEDLINE | ID: mdl-33601005

ABSTRACT

BACKGROUND: Infectious complications after hernia operation are potentially disastrous, often requiring long-term antibiotic administration, debridement, and mesh explantation. Our objective was to describe the long-term incidence and risk factors for synthetic mesh explantation due to infection after hernia operation in a large cohort. STUDY DESIGN: Retrospective database study using Veterans Affairs Surgical Quality Improvement Program and chart review of veterans undergoing abdominal or groin hernia repair with synthetic mesh implantation during 2008-2015. The main outcome was mesh explantation due to infection within 5 years. RESULTS: The study population consisted of 103,869 hernia operations, of which 74.3% were inguinal, 10.7% umbilical, and 15.0% ventral. Explantation incidence was highest among ventral (1.5%). Median explantation interval overall was 208 days. In multivariable logistic regression, all obesity levels from pre-obesity to obesity class III were associated with higher explantation risk. American Society of Anesthesiology physical status classification of 3 to 5 was associated with odds ratio (OR) of 1.7 (95% CI, 1.28 to 2.26), as was longer operative duration (OR 1.83; 95% CI, 1.51 to 2.21), and contaminated or dirty surgical wound classification (OR 2.27; 95% CI, 1.11 to 4.64). Umbilical repair (OR 6.11; 95% CI, 4.14 to 9.02) and ventral repair (OR 14.35; 95% CI, 10.39 to 19.82) were associated with higher risk compared with inguinal. Open repair was associated with a higher risk compared with laparoscopic (OR 3.57; 95% CI, 2.52 to 5.05). Deep incisional surgical site infection within 30 days of operation was more likely to result in long-term mesh explantation (29.2%) than either superficial (6.4%) or organ space infection (22.4%). CONCLUSIONS: Mesh explantation for infection is most common after ventral hernia repair. Risk factor optimization is crucial to minimize such an end point.


Subject(s)
Device Removal/statistics & numerical data , Herniorrhaphy , Surgical Mesh , Surgical Wound Infection/therapy , Aged , Aged, 80 and over , Female , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Risk Factors , United States , Veterans
17.
J Orthop Surg Res ; 16(1): 54, 2021 Jan 14.
Article in English | MEDLINE | ID: mdl-33446230

ABSTRACT

PURPOSE: Femoral neck fractures are still unsolved problems nowadays; sliding hip screw (SHS) and cannulated compression screw (CCS) are the most commonly used devices. We evaluated the clinical outcomes and complications in the treatment of femoral neck fractures between SHS and CCS in this meta-analysis to find which is better. METHODS: We searched PubMed, Embase, Cochrane library up to 24 August 2020 and retrieved any studies comparing sliding hip screw and cannulated compression screw in treatment of femoral neck fractures; the main outcomes and complications were extracted from the studies which were included. RESULTS: Nine studies involving 1662 patients (828 patients in the SHS group and 834 patients in the CCS group) were included in this study. SHS had higher rate of avascular necrosis (RR = 1.30, 95% CI 1.08-1.56, p = 0.005), and CCS had higher rate of implant removal (RR = 0.63, 95% CI 0.43-0.93, p = 0.02). No significant statistical difference in non-union, implant failure, infection, replacement, mortality, orthopedic complications, non-orthopedic complications, and total revision between SHS and CCS group. CONCLUSION: Both devices have their pros and cons; SHS had a higher rate of avascular necrosis, and CCS had a higher rate of implant removal rate. No significant statistical difference in non-union, implant failure, infection, replacement, mortality, orthopedic complications, non-orthopedic complications, and total revision between SHS and CCS group.


Subject(s)
Bone Screws , Femoral Neck Fractures/surgery , Fracture Fixation, Internal/methods , Device Removal/statistics & numerical data , Female , Humans , Male , Osteonecrosis/epidemiology , Osteonecrosis/etiology , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Reoperation/statistics & numerical data , Treatment Outcome
18.
J Bone Joint Surg Am ; 103(8): 705-714, 2021 04 21.
Article in English | MEDLINE | ID: mdl-33411462

ABSTRACT

BACKGROUND: There is a lack of evidence regarding long-term outcomes of rotating-hinge knee prostheses with distal femoral replacement in a large oncologic patient series. In this study, we investigated the proportion of patients experiencing complications requiring surgery in the long term, as well as the cumulative incidence of implant removal/revision and amputation at 5, 10, 15, and 20 years through competing risk analyses. METHODS: We retrospectively studied 214 patients treated with a Finn/Orthopaedic Salvage System (OSS) knee prosthesis (Zimmer Biomet) after distal femoral resection from 1991 to 2017. The study end points were postoperative complications requiring surgery. Reoperations were classified as major when there was (1) removal of the metal-body femoral component, the tibial component, or the bone-implant fixation; (2) major revision (exchange of the metal-body femoral component, the tibial component, or the bone-implant fixation); or (3) amputation. Minor reoperations were defined as all other reoperations. Competing risk analysis was used to estimate the cumulative incidence of implant removal/revision or amputation. RESULTS: There were 312 reoperations in 113 patients (98 major reoperations in 68 patients and 214 minor reoperations). Seventeen patients (8%) required ≥5 additional operations, and 21 patients (10%) required >1 major reoperation. Although the number of reoperations decreased over time, major and minor reoperations continuously accrued after 10 years. The cumulative incidences of implant removal or revision for any reason at 5, 10, 15, and 20 years were 22.6%, 30.1%, 34.3%, and 42.5%, respectively. Although most implant removals/revisions occurred in the first 10 years, the risk persisted after 10 years, at a mean of 1.24%/year, mainly due to deep infection (1.06%/year). CONCLUSIONS: The long-term outcomes of treatment with a Finn/OSS distal femoral rotating-hinge knee prosthesis showed it to be a durable reconstruction technique. The rate of implant removal/revisions after 10 years was gradual (1.24%/year). Deep infection remains a major late-failure mechanism, and lifetime surveillance for prosthetic problems is needed. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.


Subject(s)
Amputation, Surgical/statistics & numerical data , Arthroplasty, Replacement, Knee/instrumentation , Femoral Neoplasms/surgery , Knee Prosthesis , Limb Salvage/instrumentation , Postoperative Complications/surgery , Reoperation/statistics & numerical data , Adult , Arthroplasty, Replacement, Knee/methods , Device Removal/statistics & numerical data , Female , Follow-Up Studies , Giant Cell Tumor of Bone/surgery , Histiocytoma, Malignant Fibrous/surgery , Humans , Male , Middle Aged , Postoperative Complications/epidemiology , Prosthesis Failure , Retrospective Studies , Sarcoma/surgery
19.
World J Urol ; 39(8): 3057-3062, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33388876

ABSTRACT

PURPOSE: Although artificial urinary sphincter (AUS) has become an established treatment for moderate to severe stress urinary incontinence (SUI), implantation can be challenging. This study aimed to review the outcomes of laparoscopic AUS (LAUS) implantation and revision in women presenting with SUI. METHODS: We reviewed the files of female patients presenting with moderate to severe SUI treated with LAUS implantation from October 2007 to July 2017. Surgeries were performed by one surgeon experienced in open AUS implantation and starting LAUS implantation. The primary endpoint was postoperative urinary continence, which was divided into three categories: complete continence, improved continence, and unchanged incontinence. The secondary outcomes were complications, explantation-free and revision-free time. RESULTS: A total of 49 women (mean age 64 years, range 40-80) had LAUS implantation. Among the 42 patients (85.7%) with an AUS in place at the last follow-up, 25 (59.5%) were fully continent, 16 (38.1%) had improved continence, and 1 (2.4%) had unchanged incontinence. At the last follow-up, 29 (59.2%) patients had their initial AUS and 13 (26.5%) had at least one reintervention. There were 9 (18.4%) intraoperative complications and 25 (51%) postoperative complications, of which 9 (18.4%) were Clavien⩾3. After a median follow-up of 4 years, 9 (18.4%) explantations and 11 (22.5%) revisions occurred. The average period without explantation or revision was 3.7 and 3.1 years, respectively. CONCLUSION: Our study shows that the laparoscopic approach for AUS implantation is an efficient treatment option for women with moderate to severe SUI.


Subject(s)
Laparoscopy , Postoperative Complications , Prosthesis Implantation , Reoperation , Urinary Incontinence, Stress , Urinary Sphincter, Artificial , Device Removal/statistics & numerical data , Female , France/epidemiology , Humans , Laparoscopy/methods , Laparoscopy/statistics & numerical data , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/physiopathology , Postoperative Complications/surgery , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Prosthesis Implantation/methods , Reoperation/methods , Reoperation/statistics & numerical data , Retrospective Studies , Severity of Illness Index , Treatment Outcome , Urinary Incontinence, Stress/diagnosis , Urinary Incontinence, Stress/epidemiology , Urinary Incontinence, Stress/physiopathology , Urinary Incontinence, Stress/surgery , Urinary Sphincter, Artificial/adverse effects , Urinary Sphincter, Artificial/statistics & numerical data
20.
Laryngoscope ; 131(7): E2363-E2370, 2021 07.
Article in English | MEDLINE | ID: mdl-33382113

ABSTRACT

OBJECTIVES/HYPOTHESIS: To determine the rate and predictors of receiving multiple tympanostomy tube (TT) placements in children. STUDY DESIGN: Systematic review and meta-analysis. METHODS: PubMed, EMBASE, and Cochrane Library databases were searched for studies reporting the risk factors for receiving repeat TT (r-TT) placements in children with chronic otitis media with effusion or recurrent acute otitis media. These articles were systematically reviewed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) recommendations. Data were pooled using a random-effects model. RESULTS: Twenty-one studies involving a total of 290,897 children were included. Among all patients, 24.1% (95% confidence interval (CI), 18.2%-29.9%) underwent ≥2 TT placements and 7.5% (95% CI, 5.7%-9.4%) underwent ≥3 TT placements. Craniofacial disease (odds ratio (OR) 5.13, 95% CI, 1.57-16.74) was the strongest predictor of r-TT. Younger age at initial TT placement and shorter TT retention time were also significantly associated with r-TT. Receipt of primary adenoidectomy with initial TT placement was associated with decreased odds of r-TT (OR, 0.46; 95% CI, 0.39-0.55). Long-term tubes also significantly reduced the odds of r-TT (OR, 0.27; 95% CI, 0.17-0.44). CONCLUSIONS: About 1 in 4 children receiving TT will receive at least one repeat set of TT and about 1 in 14 will receive multiple repeat sets. Concurrent adenoidectomy and long-term tubes reduced the incidence of r-TT. Younger patients and those with earlier extrusion of the initial set are at increased risk for repeat surgery. The identification of these risk factors may improve parental counseling and identify patients who might benefit from closer follow-up. LEVEL OF EVIDENCE: NA Laryngoscope, 131:E2363-E2370, 2021.


Subject(s)
Adenoidectomy/statistics & numerical data , Device Removal/statistics & numerical data , Middle Ear Ventilation/statistics & numerical data , Otitis Media/surgery , Reoperation/statistics & numerical data , Aftercare , Child , Chronic Disease/therapy , Humans , Middle Ear Ventilation/instrumentation , Protective Factors , Recurrence , Risk Factors , Time Factors , Treatment Outcome
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