True Incidence Of Complications Research Articles

Morbidity and mortality following degenerative spine surgery in a prospective cohort of 1687 consecutive surgical procedures.

Prospective, observational cohort study. To determine the true incidence of adverse events (AEs) in European adults undergoing surgery for degenerative spine diseases. The majority of surgeries performed for degenerative spinal diseases are elective, and the need for adequate estimation of risk-benefit of the intended surgery is imperative. A cumbersome obstacle for adequate estimation of surgery-related risks is that the true incidence of complications or adverse events (AEs) remains unclear. All adult patients (≥ 18 years) undergoing spine surgery at a single center from February 1, 2016, to January 31, 2017, were prospectively and consecutively included. Morbidity and mortality were determined using the Spine AdVerse Events Severity (SAVES) system. Additionally, the correlation between the AEs and length of stay (LOS) and mortality was assessed. A total of 1687 procedures were performed in the study period, and all were included for analysis. Of these, 1399 (83%) were lumbar procedures and 288 (17%) were cervical. The overall incidence of AEs was 47.4%, with a minor AE incidence of 43.2% and a major of 14.5%. Female sex (OR 1.5 [95% CI 1.2-1.9), p < 0.001) and age > 65 years (OR 1.5 [95% CI 1.1-1.7], p = 0.012) were significantly associated with increased odds of having an AE. Based on prospectively registered AEs in this single-center study, we validated the use of the SAVES system in a European population undergoing spine surgery due to degenerative spine disease. We found a higher incidence of AEs than previously reported in retrospective studies. The major AEs registered occurred significantly more often perioperatively and in patients > 65 years.

Underreporting of Robotic Surgery Complications

Since its Food and Drug Administration (FDA) approval, robot-assisted laparoscopic surgery has grown with expanding indications. One factor used to expand indications is device-related complications. We designed a study to evaluate device-related robotic surgery complications reported to FDA. We searched the FDA device-related complication database, LexisNexis, and PACER (Public Access to Court Electronic Records) to identify robotic surgery-related complications over a 12-year period (January 1, 2000 to August 1, 2012). Cases from LexisNexis and PACER were cross-referenced with the FDA database to determine cases where an FDA report was inaccurate, filed late or not filed. A total of 245 events were reported to the FDA during the study period, including 71 deaths and 174 nonfatal injuries. Median time to report an event to the FDA was 30 days (range = 0-930 days). Eight cases were identified from the LexisNexis and PACER searches where FDA reports were improperly filed. In five of these, no report was filed with a mean follow-up of 4.1 years (range = 2.3-5.8 years). In the three cases where a report was filed, the mean time between the event and the FDA report was 20.4 months (611 days, range = 292-930 days). It is important that the true incidence of complications with robotic-assisted laparoscopic surgery be known to ensure continued safe innovation.

Complications of Arthroscopic Shoulder Surgery

Shoulder arthroscopic procedures have become common in today's orthopedic practice. The safety of shoulder arthroscopy though well established, is not without complications both minor and significant. The true incidence of complications is difficult to identify in the current literature. However, as with all procedures, complications associated with shoulder arthroscopy do occur. General complications (ie, infection), those specific to shoulder arthroscopy (ie, positioning) and those associated with specific procedures (ie, failure) all have been recognized. The purpose of this article is to review the current literature regarding complications in shoulder arthroscopy, provide insight into the risk factors and types of complications and to provide guidelines on the prevention and management of complications if and when they occur.

Corticosteroid Injections in the Treatment of Foot &amp; Ankle Disorders: An AOFAS Survey

Evidence-based guidelines for the use of injectable corticosteroids are lacking, and the true incidence of complications is unknown. The 2007--2008 AOFAS membership (969 members) was electronically queried to identify corticosteroid injection practices for certain clinical entities and rates of complications. One hundred ninety-seven surveys were returned. Eleven clinical diagnoses were evaluated for number of injections per year per respondent, rate of injection, plans to change injection pattern, and use of immobilization. Thirteen possible complications were analyzed for observed frequencies and total number of complications. Those in practice less than 5 years showed the lowest rate of injections at 14.1 per month, which increased to 26.1 for those in practice 6 to 10 years. An overall average of 20.6 injections per month per clinician was reported. Injections for midsubstance Achilles tendinopathy was largely avoided as demonstrated by a 98% no-inject rate. Insertional Achilles tendonitis was similar, albeit lower with an 88% no-inject rate. Non-Achilles tendonitis showed a varied response for injections. Posterior tibial tendonitis was injected 26% of the time, whereas peroneal tendonitis was injected 54% of the time. Complications including skin depigmentation were observed most frequently (5.1%), followed by atrophy (4%), flare reaction (3.5%), MTPJ dislocation (2.7%), plantar fascia rupture (1.5%), and heel pad atrophy (1.4%). Despite many case reports of complications, our survey indicates that the incidence of complications was perceived to be low and generally related to the injection site (skin depigmentation, atrophy, flare reaction).

A Single Surgeon???s 12-Year Experience with Tissue Expander/Implant Breast Reconstruction: Part I. A Prospective Analysis of Early Complications

Multiple prior reports are conflicted regarding the true incidence of complications following implant-based breast reconstruction. A review of a single surgeon's extensive experience with tissue expander/implant reconstruction provides the opportunity to critically evaluate outcomes in a uniformly treated patient population. The objective of this study was to analyze the development of early complications in patients following two-stage implant breast reconstruction. A review of all tissue expander/implant reconstructions performed by a single surgeon over the 12-year period from July of 1992 to June of 2004 was performed. A prospectively maintained database was analyzed with respect to reconstructive and early complication data on 1522 reconstructions in 1221 patients. Early complications were defined as those occurring 12 months or less from initiation of reconstruction. The overall rate of early complications was 5.8 percent; the rate of premature expander removal was 2.7 percent. The most common complication was infection (2.5 percent). The incidence of complications after tissue expander insertion (8.5 percent) was significantly higher than that after the exchange procedure (2.7 percent). The rate of complications was significantly higher in patients with a history of preoperative chest wall irradiation. There was no difference in the incidence of complications in patients who were expanded during chemotherapy and those who were not. Tissue expander/implant reconstruction is a safe, reliable method of reconstruction with minimal early complications. Early complications are more common after expander insertion. Chemotherapy administered during tissue expansion does not increase the rate of complications. The rate of complications, although higher in previously irradiated patients, remains low.

Anticoagulation Clinic: A Safety Net

Oral anticoagulation with Coumadin (warfarin) is becoming more frequent as the US and global population ages and encounters those conditions considered appropriate for anticoagulation therapy.1 Two keys to therapeutic success are education and communication, both of which may be in short supply in a busy clinic or physician's office and which may be shortchanged despite good intentions on the part of both the patient and the physician. While the true incidence of complications from excessive or insufficient warfarin therapy is unknown, it is likely greater in the experience of any one physician or clinic if each physician manages his/her own patients. Complications do occur under the best of circumstances and to those with the best of intentions. The effectiveness and safety of warfarin therapy require maintenance of an international normalized ratio (INR) within a therapeutic range established for a variety of conditions. There are a number of predictors that may trigger a nontherapeutic INR: gender, age, body-mass index, height, weight, ethnicity, tobacco and alcohol abuse, interacting medications, vitamins, herbal supplements, dosage intensity, comorbid conditions, diet, frequency of INR testing and warfarin knowledge, to name a few.2-10 There is growing support for the concept of anticoagulation clinics. 11•13 Some early evidence suggests therapeutic INR levels are more consistently obtained in clinics monitored by physicians or allied personnel such as nurses, pharmacists and physicians' assistants11-16 and through self-testing as an extension of a clinic setting.11-2° Currently, there is no uniform consensus on whether Coumadin or warfarin is the preferred anticoagulant.21

The degree of reliability of data obtained using a computer registry of patients with non-insulin-dependent diabetes mellitus

The main problem in analysis of the register of diabetes mellitus is evaluation of the reliability of data and the probability of extrapolating the results to a population of patients in the studied region. Our task was to assess the efficacy of diagnostic methods used in a region. Study of the prevalence of diabetic retinopathy and neuropathy by referent tests revealed poor sensitivity of methods for diagnosis of these complications in patients with insulin-dependent diabetes mellitus (IDDM) in the Mytischi region; hence, the prevalence of diabetic retinopathy and neuropathy might be higher than recorded in IDDM register.&#x0D; Analysis confirmed the usefulness of active detection of early stages of complicated IDDM by screening (examination of the fundus oculi, detection of microalbuminuria and vibration sensitivity) for reflecting the true incidence of complications and timely therapy. Detection of numerous patients with IDDM at the phase of diabetes decompensation necessitates revision of preventive and therapeutic measures. High incidence of hypoglycemic reactions among IDDM patients necessitates their more active prevention, specifically, training IDDM patients to practice automonitoring methods.

Percutaneous Ultrasound Procedures for the Treatment of Kidney Stones

Percutaneous lithotripsy has achieved widespread diffusion throughout the medical community and is described by many authors as the manipulative treatment of choice in an increasing number of patients with renal stones. Appropriate use of percutaneous lithotripsy is not an isolated event of patient management but is considered to be one episode in the medical#surgical management of nephrolithiasis. Medical management must be initiated at the first determination of the presence of the stone or at the time of the diagnosis of one of the underlying conditions which predispose to stone formation. In spite of the fact that no randomized prospective trial studies are available, the overall preponderance of the available information is that percutaneous lithotripsy for the treatment of kidney stones is a safe and efficacious procedure. In addition, it has achieved widespread acceptance and is generally employed throughout the country. Cooperation between the physician responsible for medical management of the patient, the urologist, and the radiologist appears to be an essential ingredient for successful management. Long-term studies are indicated to determine the true incidence of complications and the long-range effects of the procedures employed by the percutaneous route.