Defining Benchmark Outcomes for ALPPS

Abstract

Objective: The aim of this study was to use the concept of benchmarking to establish robust and standardized outcome references after the procedure ALPPS (Associating Liver Partition and Portal Vein Ligation for Staged hepatectomy). Background and Aims: The recently developed ALPPS procedure, aiming at removing primarily unresectable liver tumors, has been criticized for safety issues with high variations in the reported morbidity/mortality rates depending on patient, disease, technical characteristics, and center experience. No reference values for relevant outcome parameters are available. Methods: Among 1036 patients registered in the international ALPPS registry, 120 (12%) were benchmark cases fulfilling 4 criteria: patients ≤67 years of age, with colorectal metastases, without simultaneous abdominal procedures, and centers having performed ≥30 cases. Benchmark values, defined as the 75th percentile of the median outcome parameters of the centers, were established for 10 clinically relevant domains. Results: The benchmark values were completion of stage 2: ≥96%, postoperative liver failure (ISGLS-criteria) after stage 2: ≤5%, ICU stay after ALPPS stages 1 and 2: ≤1 and ≤2 days, respectively, interstage interval: ≤16 days, hospital stay after ALPPS stage 2: ≤10 days, rates of overall morbidity in combining both stage 1 and 2: ≤65% and for major complications (grade ≥3a): ≤38%, 90-day comprehensive complication index was ≤22, the 30-, 90-day, and 6-month mortality was ≤4%, ≤5%, and 6%, respectively, the overall 1-year, recurrence-free, liver-tumor-free, and extrahepatic disease-free survival was ≥86%, ≥50%, ≥57%, and ≥65%, respectively. Conclusions: This benchmark analysis sets key reference values for ALPPS, indicating similar outcome as other types of major hepatectomies. Benchmark cutoffs offer valid tools not only for comparisons with other procedures, but also to assess higher risk groups of patients or different indications than colorectal metastases.

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“…Unfortunately, a high 90‐day mortality (12%) was observed following ALPPS, which raised skepticism 5 . Since then, due to better patient selection and the refinement of the surgical technique, morbidity and mortality rates decreased 6,7 . Nevertheless, ALPPS still carries significant risks of mortality and morbidity.…”

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“…With accumulating experience in some expert centers, ALPPS has been re-considered for non-CRLM tumor entities like neuroendocrine liver metastases [93], intrahepatic CC [94], HCC [95,96], and PHC [97] in selected cases. In an attempt to define reference values for ALPPS, a recent benchmark analysis focusing on a low-risk [43] 2 0 0 4 3 3 1 0 0 3 1 -7 6 5 6 0 Tanaka et al [48] 2 0 0 7 2 2 7 3 5 0 -1 0 0 2 3 0 Wicherts et al [49] 2 0 0 8 5 9 7 8 -1 2 6 6 9 5 9 7 Homayounfar et al [50] population with CRLM found a 90-day mortality rate ≤ 5%, major complications (Clavien-Dindo grade ≥ 3a) ≤65%, postoperative liver failure after stage 2: ≤5%, and completion of stage 2 surgery ≥96% [98]. Of note, in this population, the FLR increased from 0.21% (SD 0.12) to 0.41 (SD 0.09) after a median interstage interval of 13 days [98].…”

“…In an attempt to define reference values for ALPPS, a recent benchmark analysis focusing on a low-risk [43] 2 0 0 4 3 3 1 0 0 3 1 -7 6 5 6 0 Tanaka et al [48] 2 0 0 7 2 2 7 3 5 0 -1 0 0 2 3 0 Wicherts et al [49] 2 0 0 8 5 9 7 8 -1 2 6 6 9 5 9 7 Homayounfar et al [50] population with CRLM found a 90-day mortality rate ≤ 5%, major complications (Clavien-Dindo grade ≥ 3a) ≤65%, postoperative liver failure after stage 2: ≤5%, and completion of stage 2 surgery ≥96% [98]. Of note, in this population, the FLR increased from 0.21% (SD 0.12) to 0.41 (SD 0.09) after a median interstage interval of 13 days [98]. A Scandinavian multicenter RCT comparing ALPPS and TSH in 100 patients confirms the evidence from single, retrospective series and registry data that ALPPS is associated with significantly higher resection rates (ALPPS, 92% vs. TSH, 57%).…”

“…In an attempt to define reference values for ALPPS, a recent benchmark analysis focusing on a low-risk population with CRLM found a 90-day mortality rate ≤ 5%, major complications (Clavien-Dindo grade ≥ 3a) ≤65%, postoperative liver failure after stage 2: ≤5%, and completion of stage 2 surgery ≥96% [ 98 ]. Of note, in this population, the FLR increased from 0.21% (SD 0.12) to 0.41 (SD 0.09) after a median interstage interval of 13 days [ 98 ].

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“…Nevertheless, an establishment of clinical databases from international centers with an accurate collection of demographic, management, and outcome data for respective surgical procedures is needed. The importance of establishing benchmarks has been demonstrated for various surgical procedures in general and visceral surgery (11)(12)(13)(14)(15). As yet, there is very little published about acceptable neurosurgical benchmarks.…”