The Impact of Surgical Approach on Late Recurrence in Incisional Hernia Repair.

BACKGROUND AND OBJECTIVES: We conducted a retrospective, observational study to compare real-world recurrence rates for different surgical approaches after incisional hernia mesh repair. METHODS: Two large US insurance claims databases, Truven Commercial Claims (CCAE) and Medicare Supplemental (MDCR), were evaluated for the period from 2009 to 2015. The first incisional hernia repair with mesh for patients 21 years or older was identified (INDEX). One-year continuous enrollment before INDEX was required. Mesh and approach (OPEN, laparoscopic [LAP], and conversion [CONV]) were identified with the use of CPT-4/ICD-9 codes. Recurrence was defined as a second incisional hernia repair 31 days or longer after INDEX. Kaplan-Meier (KM) estimates and Cox models were used to analyze the effect of approach on recurrence. RESULTS: A total of 68,560 patients were identified for CCAE (78.7%) and MDCR (21.3%) with a mean (SD) age of 55.3 (12.8) years. The majority of procedures were OPEN (80.1%) followed by LAP (16.3%) and CONV (3.6%). OPEN had fewer female patients 53.7% compared with LAP (62.1%) and CONV (62.2%). CONV represented more inpatient (51.9%) procedures compared with LAP (41.0%) and OPEN (27.3%). Starting at 2 years post-INDEX, LAP (5.1%, 95% confidence interval [CI] 4.5%-5.6%) had lower KM estimates compared with OPEN (5.9%, 95% CI 5.7%-6.2%]); after 3 years, LAP (6.8%, 95% CI 6.2%-7.5%]) had lower estimates than both OPEN (7.9%, 95% CI 7.6%-8.3%) and CONV (9.3%, 95% CI 7.6%-11.0%). After controlling for confounders, the risk was lower for LAP compared with OPEN (hazard ratio 0.839, 95% CI 0.752-0.936) and CONV (hazard ratio 0.808, 95% CI 0.746-0.875), while OPEN and CONV were not significantly different from each other. CONCLUSION: Successful laparoscopic surgery incisional hernia mesh repair was associated with decreased risk of recurrence compared with OPEN and CONV.

Contrast medium-induced acute kidney injury: comparison of intravenous and intraarterial administration of iodinated contrast medium.

PURPOSE: To compare the incidence of contrast medium-induced acute kidney injury (AKI) after intravenous (IV) administration of iodixanol for computed tomographic (CT) angiography versus intraarterial (IA) injection of iodixanol or low osmolar contrast medium (LOCM) for digital subtraction angiography (DSA) within the same population suspected of peripheral arterial occlusive disease (PAOD). MATERIALS AND METHODS: CT angiography was performed with IV iodixanol 320 mgI/mL. After a washout period of 3-14 days, DSA was performed with IA iodixanol or LOCM. Serum creatinine was measured at baseline and 24 hours after administration. Contrast medium-induced AKI was defined by a serum creatinine increase of at least 25% versus baseline at 24 hours. Data were analyzed with χ(2) statistics. RESULTS: Mean baseline serum creatinine values were comparable between CT angiography with IV contrast medium and DSA with IA contrast medium (93.3 µmol/L ± 52.92 vs 92.8 µmol/L ± 61.70). The incidence of AKI for CT angiography after IV iodixanol administration was 7.6% (20 of 264), which was not statistically different than the 8.7% incidence (22 of 253) for DSA with IA iodixanol or LOCM (P = .641). In the 143 patients who received only iodixanol for both procedures, incidences of contrast medium-induced AKI were comparable after IV (7.0%) and IA (5.6%) administration (P = .626). CONCLUSIONS: The rates of contrast medium-induced AKI are not statistically different between IV iodixanol for CT angiography and IA iodixanol or another LOCM for DSA in the same population with suspected PAOD.

Contrast-induced acute kidney injury (CI-AKI) following intra-arterial administration of iodinated contrast media.

BACKGROUND: We report the incidence of contrast-induced acute kidney injury (CI-AKI) following administration of iodixanol or low-osmolar contrast media (LOCM) in patients for suspected peripheral arterial occlusive disease (PAOD) undergoing intra-arterial digital angiography (IA-DSA). METHODS: IA-DSA was performed according to site standard for contrast agent type and volume following computed tomography (CT) of the abdominal aortoiliac and lower extremity arteries and a washout period of at least 3 days. Serum creatinine was measured at baseline and 24 ± 4 hours after contrast administration. CI-AKI was defined as laboratory increase of serum creatinine value =25% from baseline measurement at 24 hours. The incidence of CI-AKI was analyzed with chi-square statistics. RESULTS: Of the 250 patients who underwent IA-DSA with complete data for analysis, 147 (58.8%) received iodixanol and 103 (41.2%) received LOCM (iopamidol, 91; ioversol, 7; iohexol, 3; iopromide, 2). Baseline mean serum creatinine was statistically higher for iodixanol compared with LOCM (100 vs. 82.7 µmol/L; p=0.0124). CI-AKI occurred in 8 patients (5.4%) with iodixanol and 14 patients (13.6%) with LOCM (p=0.025). Further analysis showed that iopamidol administration was responsible for the 13 out of 14 cases of CI-AKI in LOCM patients. CONCLUSIONS: In patients with suspected PAOD undergoing IA-DSA, the incidence of CI-AKI at 24 hours following contrast administration was significantly less for patients who received iodixanol compared with various LOCM; this difference was primarily driven by iopamidol.

Comparison of contrast-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of peripheral arterial occlusive disease: results of a phase III multicenter trial.

PURPOSE: To evaluate the efficacy and safety of 0.1 mmol/kg gadodiamide administration for contrast-enhanced magnetic resonance angiography (CE-MRA) in detecting hemodynamically relevant main stenosis (ie, > or = 50% or occlusion) of aortoiliac arteries. MATERIALS AND METHODS: In a multicenter, phase 3, controlled study, patients with suspected or proven peripheral arterial occlusive disease (PAOD) underwent CE-MRA with administration of gadodiamide. Intraarterial digital subtraction angiography (IA-DSA) was used as the reference. The study was approved by all Institutional Review Boards or Institutional Ethic Committees prior to commencement of patient recruitment and written informed consent was obtained from all patients. RESULTS: Independent readers rated 25%-45% of CE-MRA images as excellent compared with 0.3%-6% of noncontrast MRA images. Mean imaging acquisition time for CE-MRA was <1 minute (0.7 +/- 1.9 minutes) versus 10 minutes (10.8 +/- 3.0) for noncontrast MRA. Sensitivity, specificity, and accuracy of CE-MRA were superior compared with those of noncontrast MRA in detecting significant arterial stenoses. Compared with IA-DSA, the sensitivity of CE-MRA ranged from 80%-88% and the specificity from 73% to 92% for the three blinded readers, at the patient level. CONCLUSION: Diagnostic results with CE-MRA were superior and more consistent compared with noncontrast MRA for detecting hemodynamically relevant main stenoses in patients with suspected or proven PAOD and compared favorably with IA-DSA as a reference standard.

Comparison of gadodiamide-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: results of a phase III multicenter trial.

PURPOSE: To evaluate the efficacy and safety of 0.1 mmol/kg gadodiamide administration for contrast-enhanced magnetic resonance angiography (MRA) in detecting hemodynamically relevant renal artery stenosis (RAS) when compared with intraarterial digital subtraction angiography (IA-DSA) as the gold standard. MATERIALS AND METHODS: In a multicenter, controlled study, 395 patients with suspected or known RAS were included. Three independent readers evaluated the MRA images. Two readers evaluated the IA-DSA images and subsequently achieved consensus. The sensitivities and specificities of gadodiamide-enhanced MRA were analyzed at the per-patient and per-vessel levels (exact 1-sided binomial test at alpha = 0.025 with 95% confidence interval). RESULTS: A total of 335 patients who had available standard of truth and MRA tests were included in the all-subjects efficacy population: 55.5% (186/335) men and 44.5% women with a mean age of 63 +/- 13 years (range 17-85 years). The sensitivities and specificities ranged from 81% to 86% for all independent readers at the per-patient analysis based on subjects with the diagnostic images. Similar results were achieved with per-vessel level analysis. Fewer than 1% of patients had adverse event associated with gadodiamide administration. There were no cases of nephrogenic systemic fibrosis (NSF) reported. CONCLUSION: Gadodiamide administration at the labeled dose of 0.1 mmol/kg for contrast-enhanced MRA achieved equivalent results compared to IA-DSA in evaluation of RAS and was well tolerated.