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Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis.

ABSTRACT: Central venous catheters remain a vital option for access for patients receiving maintenance hemodialysis. There are many important and evolving clinical and regulatory considerations for all stakeholders for these devices. Innovation and transparent and comprehensive regulatory review of these devices is essential to stimulate innovation to help promote better outcomes for patients receiving maintenance hemodialysis. A workgroup that included representatives from academia, industry, and the US Food and Drug Administration was convened to identify the major design considerations and clinical and regulatory challenges of central venous catheters for hemodialysis. Our intent is to foster improved understanding of these devices and provide the foundation for strategies to foster innovation of these devices.

SUBMITTER: Silverstein DM

PROVIDER: S-EPMC6302318 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis.

Silverstein Douglas M DM Trerotola Scott O SO Clark Timothy T James Garth G Ng Wing W Dwyer Amy A Florescu Marius C MC Shingarev Roman R Ash Stephen R SR

Clinical journal of the American Society of Nephrology : CJASN 20181011 12

Central venous catheters remain a vital option for access for patients receiving maintenance hemodialysis. There are many important and evolving clinical and regulatory considerations for all stakeholders for these devices. Innovation and transparent and comprehensive regulatory review of these devices is essential to stimulate innovation to help promote better outcomes for patients receiving maintenance hemodialysis. A workgroup that included representatives from academia, industry, and the US ...[more]

PMID: 30309840

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Project description:Use of peripherally inserted central catheters has expanded rapidly, but the consequences for patients who eventually require hemodialysis are undefined.Our national, population-based analysis included 33,918 adult Medicare beneficiaries from the US Renal Data System who initiated hemodialysis with central venous catheters as their sole vascular access in 2010 and 2011. We used linked Medicare claims to identify peripherally inserted central catheter exposures and evaluate the associations of peripherally inserted central catheter placement with transition to working arteriovenous fistulas or grafts and patient survival using a Cox model with time-dependent variables.Among 33,918 individuals initiating hemodialysis with a catheter as sole access, 12.6% had received at least one peripherally inserted central catheter. Median follow-up was 404 days (interquartile range, 103-680 days). Among 6487 peripherally inserted central catheters placed, 3435 (53%) were placed within the 2 years before hemodialysis initiation, and 3052 (47%) were placed afterward. Multiple peripherally inserted central catheters were placed in 30% of patients exposed to peripherally inserted central catheters. Recipients of peripherally inserted central catheters were more likely to be women and have comorbid diagnoses and less likely to have received predialysis nephrology care. After adjustment for clinical and demographic factors, peripherally inserted central catheters placed before or after hemodialysis initiation were independently associated with lower likelihoods of transition to any working fistula or graft (hazard ratio for prehemodialysis peripherally inserted central catheter, 0.85; 95% confidence interval, 0.79 to 0.91; hazard ratio for posthemodialysis peripherally inserted central catheter, 0.81; 95% confidence interval, 0.73 to 0.89).Peripherally inserted central catheter placement was common and associated with adverse vascular access outcomes. Recognition of potential long-term adverse consequences of peripherally inserted central catheters is essential for clinicians caring for patients with CKD.

Project description:BackgroundDespite well-publicized suggestions to utilize arteriovenous fistulae and grafts to initiate hemodialysis, too many patients in the United States start dialysis via central venous catheters despite their well-known association with increased morbidity, mortality, and cost.MethodsTo determine the reasons for this high rate of catheter use, and, ultimately, ways to reduce it, we developed a questionnaire designed to determine where in the process of patient care the process to fistula or graft placement was not completed, thus requiring the use of central venous catheters. The questionnaire was reviewed by several nephrologists not involved with the study. We administered the questionnaire to 52 consecutive hospitalized patients who started maintenance dialysis with catheters at a University-affiliated Hospital and referral center. The questionnaire asked each patient to provide details pertaining to pre-dialysis care, referrals, and follow-through on recommended referrals. If the patient did not see the physician to whom he/she was referred, we asked the reason(s) for such failure.ResultsPatient responses showed that there were two major lapses in the transition from diagnosis of advanced kidney disease to construction of appropriate dialysis access: failure by the patients to see a nephrologist and/or an access surgeon, and failure by physicians to refer patients to an access surgeon. Twenty percent of the patients failed to follow up with either a nephrologist or a surgeon. Only 38% (15/40) of those seen by a nephrologist had been referred to a surgeon.ConclusionsThe quality of care was impaired by lack of referral to surgeons by nephrologists and by lack of follow-through by patients. Areas for improvement include improved communications between physicians and patients and more careful follow-up by both physicians and patients. Several methods of providing better patient care and communication between patients and nephrologists are recommended.

Project description:BackgroundCentral venous catheter (CVC) and hemodialysis (HD) catheter usage are associated with complications that occur during catheter insertion, dwell period, and removal. This study aims to identify and describe the incidence rates of catheter-related complications in a large patient population in a United States-based health care claims database after CVC or HD catheter placement.MethodsPatients in the i3 InVision DataMart® health care claims database with at least 1 CVC or HD catheter insertion claim were categorized into CVC or HD cohorts using diagnostic and procedural codes from the US Renal Data System, American College of Surgeons, and American Medical Association's Physician Performance Measures. Catheter-related complications were identified using published diagnostic and procedural codes. Incidence rates (IRs)/1000 catheter-days were calculated for complications including catheter-related bloodstream infections (CRBSIs), thrombosis, embolism, intracranial hemorrhage (ICH), major bleeding (MB), and mechanical catheter-related complications (MCRCs).ResultsThirty percent of the CVC cohort and 54% of the HD cohort had catheter placements lasting <90 days. Catheter-related complications occurred most often during the first 90 days of catheter placement. IRs were highest for CRBSIs in both cohorts (4.0 [95% CI, 3.7-4.3] and 5.1 [95% CI, 4.7-5.6], respectively). Other IRs in CVC and HD cohorts, respectively, were thrombosis, 1.3 and 0.8; MCRCs, 0.6 and 0.7; embolism, 0.4 and 0.5; MB, 0.1 and 0.3; and ICH, 0.1 in both cohorts. Patients with cancer at baseline had significantly higher IRs for CRBSIs and thrombosis than non-cancer patients. CVC or HD catheter-related complications were most frequently seen in patients 16 years or younger.ConclusionsThe risk of catheter-related complications is highest during the first 90 days of catheter placement in patients with CVCs and HD catheters and in younger patients (≤16 years of age) with HD catheters. Data provided in this study can be applied toward improving patient care.

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Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis.

Publications

Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis.

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