BACKGROUND: Leadless pacemakers may be preferred in patients with limited vascular access and high-infection risk, such as patients on hemodialysis.
METHODS: Patients on hemodialysis at the time of Micra implantation attempt (n = 201 of 2,819; 7%) from the Micra Transcatheter Pacing Study investigational device exemption trial, Micra Transcatheter Pacing System Continued Access Study Protocol, and Micra Transcatheter Pacing System Post-Approval Registry were included in the analysis. Baseline characteristics, periprocedural outcomes, and intermediate-term follow-up were summarized.
RESULTS: Patients on hemodialysis at the time of Micra implantation attempt were on average 70.5 ± 13.5 years of age and 59.2% were male. The dialysis patients commonly had hypertension (80%), diabetes (61%), coronary artery disease (39%), and congestive heart failure (27%), and 72% had a condition that the implanting physician felt precluded the use of a transvenous pacemaker. Micra was successfully implanted in 197 patients (98.0%). Reasons for unsuccessful implantation included inadequate thresholds (n = 2) and pericardial effusion (n = 2). The median implantation time was 27 min (interquartile range: 20 to 39 min). There were 3 procedure-related deaths: 1 due to metabolic acidosis following a prolonged procedure duration in a patient undergoing concomitant atrioventricular nodal ablation and 2 deaths occurred in patients who needed surgical repair after perforation. Average follow-up was 6.2 months (range 0 to 26.7 months). No patients had a device-related infection or required device removal because of bacteremia.
CONCLUSIONS: Leadless pacemakers represent an effective pacing option in this challenging patient population on chronic hemodialysis. The risk of infection appears low with an acceptable safety profile. (Micra Transcatheter Pacing Study; NCT02004873; Micra Transcatheter Pacing System Continued Access Study Protocol; NCT02488681; Micra Transcatheter Pacing System Post-Approval Registry; NCT02536118).
STUDY DESIGN: Systematic review.
SETTING & POPULATION: Adults requiring maintenance hemodialysis.
SELECTION CRITERIA: All randomized controlled trials and trial protocols reporting vascular access outcomes identified from ClinicalTrials.gov, Embase, MEDLINE, and the Cochrane Kidney and Transplant Specialized Register from January 2011 to June 2016.
INTERVENTIONS: Any hemodialysis-related intervention.
OUTCOMES: The frequency and characteristics of vascular access outcome measures were analyzed and classified.
RESULTS: From 168 relevant trials, 1,426 access-related outcome measures were extracted and classified into 23 different outcomes. The 3 most common outcomes were function (136 [81%] trials), infection (63 [38%]), and maturation (31 [18%]). Function was measured in 489 different ways, but most frequently reported as "mean access blood flow (mL/min)" (37 [27%] trials) and "number of thromboses" (30 [22%]). Infection was assessed in 136 different ways, with "number of access-related infections" being the most common measure. Maturation was assessed in 44 different ways at 15 different time points and most commonly characterized by vein diameter and blood flow. Patient-reported outcomes, including pain (19 [11%]) and quality of life (5 [3%]), were reported infrequently. Only a minority of trials used previously standardized outcome definitions.
LIMITATIONS: Restricted sampling frame for feasibility and focus on contemporary trials.
CONCLUSIONS: The reporting of access outcomes in hemodialysis trials is very heterogeneous, with limited patient-reported outcomes and infrequent use of standardized outcome measures. Efforts to standardize outcome reporting for vascular access are critical to optimizing the comparability, reliability, and value of trial evidence to improve outcomes for patients requiring hemodialysis.
OBJECTIVE: To examine the feasibility of TV-NOSE in live donor nephrectomy.
MATERIALS AND METHODS: 53 patients received LDN surgery at our hospital from September 2017 to December 2021. Retrospectively, living donor nephrectomy with TV-NOSE was compared to three different surgical procedures with standard specimen extraction.
RESULTS: 53 donor patients were included: 15 open (OLDN), 12 retroperitoneoscopic living donor nephrectomy (RPLDN), 10 transperitoneal living donor nephrectomy (TPLDN), and 16 standard laparoscopic living donor nephrectomy with transvaginal extraction (SLLDN TV-NOSE). SLLDN TVNOSE's longer operating time (p<0.0041) did not affect graft function. SLLDN TV-NOSE and RPLDN had shorter lengths of stay and better VAS trends than open LDN and TPLDN (p<0.05). SLLDN TV-NOSE donors reported acceptable surgical outcomes and unchanged sexual function. All patients had similar discharge creatinine levels, with 1-year transplant survival of 98% and just 1 graft loss in the TPLDN group.
CONCLUSION: SLLDN TV-NOSE is equivalent to RPLDN and better than open LDN and TPLDN in terms of duration of stay, VAS score, surgical outcomes, and sexual function. TVNOSE is a safe surgical procedure with an acceptable donor complication. TV-NOSE may be safely conducted in both developed and developing countries with proper patient selection.
OBJECTIVE: Identify the predictive factors for development of CI-AKI in patients prescribed NAC.
DESIGN: Prospective, cross-sectional.
SETTING: A tertiary hospital in Malaysia.
PATIENTS AND METHODS: All adult patients who were prescribed NAC for prevention of CI-AKI were identified through an NAC drug us.age monitoring card maintained by the inpatient pharmacy. The study was conducted from March to July 2017.
MAIN OUTCOME MEASURES: Statistically significant predictive fac.tors for development of CI-AKI despite NAC administration.
SAMPLE SIZE: 152 RESULTS: The most commonly recognized risk factors for CI-AKI present in the study population were renal impairment (n=131, 86.2%), anemia (n=107, 70.4%), and diabetes mellitus (n=90, 59.2%). Hydration therapy was initiated in 128 patients (84.2%) prior to the contrast-enhanced procedure. Sixty-one (40.1%) were treated with nephrotoxic medications concomitantly with NAC. Fifteen (9.9%) patients developed AKI. Hypotension (OR: 6.02; 95% CI 1.25-28.97) and use of high contrast volume (OR: 6.56; 95% CI: 1.41-30.64) significantly increased the odds for AKI. Prior hydration therapy (OR: 0.13; 95% CI 0.03-0.59) showed protective effects.
CONCLUSION: The risk predictors identified for CI-AKI were hypotension, high contrast volume and prior hydration therapy.
LIMITATION: May not have identified other confounding factors for development of CI-AKI.
CONFLICT OF INTEREST: None.