Operative Volume of Newborn Surgery in German University Hospitals: High Volume Versus Low Volume Centers

Sir,

Respect should be paid to the authors for their honesty and self-criticism, as they analyze the detrimental fragmentation of pediatric surgical care in Germany. Concerning anorectal malformations (ARMs) and esophageal atresia/tracheoesophageal fistula (EA/TEF), they report that during 2015 to 2017, 19 German academic chairs for pediatric surgery performed 1 to 43 reconstructions in ARMs and 2 to 30 in EA/TEF per clinic, which means that there are clinics with less than one case of ARM or EA/TEF operation per year.

The volume–quality relationship in surgery is well described.[1] The more complex a surgical procedure and its perioperative care, the higher the case number necessary to reach the end of the learning curve. For operations of comparable complexity, this number is at least 50 per clinic and year.[2]

Concerning major esophageal surgery in adults, the German government first set a minimal number of 10 operations per clinic and year.[3] This number was criticized as “extremely low … in the area of the learning curve with the highest mortality risk, as researchers have shown, and urgently has to be increased.”[4] Therefore, it was raised to 26 in 2020.[5] In comparison, the German Society of Visceral Surgery requires from their competence centers concerning bariatric surgery in obesity 50 operations per year, and from their excellence centers 200.[6]

The authors label their three ranges of frequency as “high-”, “medium-,” and “low-volume centers”. In the light of the quoted evidence and with a median of two to six cases per diagnosis, clinic, and year in their study, the terms “low”, “very low,” and “extremely low” seem to be more appropriate. The clinics with the highest number of cases reported 14 in ARM and 10 in EA/TEF.

The fact that German clinics treat their patients mainly with case numbers lying in the beginning of the learning curve means that again and again complications and poor treatment occur that burden the patients for a lifetime and could be prevented by centralization, reaching a higher case number per clinic. Until now, the resistance of the majority of pediatric surgeons against centralization has proved successful. While constituting a nonfinancial conflict of interest, personal interests like surgical challenge, reputation among colleagues, etc., are given priority over the interest of the patients in better treatment results.[7]

Other European countries managed to realize a certain degree of centralization already. The Netherlands and Sweden, with pediatric surgical clinics originally already serving double the population size compared with Germany, further halved their number so that the remaining two clinics on the average correct 11 out of 20 new cases with EA/TEF and 17 out of 20 new cases with ARM per clinic and year, respectively.[8]

The 19 reporting university clinics in Germany care for 50% of the cases nationwide. A further 52 (!) pediatric surgical departments treat the other half of EA/TEF-infants and a further 70 (!) of those born with ARM. For these children, the available experience and treatment quality is on average even more scarce, especially because some non-university departments have case numbers in the reported highest tercile, leaving the fewer cases for the plethora of other clinics.

Diaphragmatic hernia stands out in this study: 188 of the 338 cases were treated in a single clinic (63 per year). Obviously, centralization is possible, if complex and expensive perioperative factors (like ECMO) prompt it. The role model, most likely for this reason, is cardiac surgery. Also, in Germany, 23 clinics perform 5,913 operations per year[9]; this means on average 257 per clinic per year—a case number most likely at the end of the learning curve.[2]

Nobody among us would make oneself or one's child be subject to major, complex surgery in a clinic performing this procedure only a few times per year or even less. The patient organization for rare diseases, European Organisation for Rare Diseases, have initiated the 24 European Reference Networks (ERNs) for rare diseases of the European Union to push through their legitimate interest in centralization. Scientifically based minimal numbers of patients treated and procedures performed constitute a part of their operational criteria.[10] The aim is to reach case numbers at the end of the learning curve. Although already realized in pediatric heart surgery, general pediatric surgery is—politically and structurally—far away from this. Translating the binding European legislation into the national standards is a painfully slow process. The German patient organization for EA/TEF, KEKS, therefore decided to certify clinics on their own, setting 26 major reconstructions as the minimal number per clinic and year.[11]

Lack of experience in pediatric surgical care in Germany once again leads to preventable poor results, even to catastrophes, which burden the patients and their families for a lifetime. The authors conclude that therefore “the discussion to centralize pediatric surgery care in Germany should be intensified.” To draw only this consequence from the analysis of this disgrace makes us very troubled and dissatisfied. Discussions for decades and first steps toward centralization (foundation of the ERNs, setting minimal numbers in adult medicine, and the German National Action League for People with Rare Diseases, NAMSE[12]) did not yet yield measurable benefits. It is clearly necessary that the analysis of the deficits leads to deeds for their correction. Therefore, we urgently ask the German Pediatric Surgical Society to press for binding minimal case numbers, at least for the rare conditions analyzed in this article. If the majority of the societies further obstruct centralization, cooperation with the governmental legislator will be mandatory to finally realize what is ethically due. The aim is set: minimal case numbers at the end of the learning curve. The next step has to be the prevention of the occasional surgery in the lowest tercile of the actual numbers.

In light of the overwhelming scientific evidence, lawsuits because of severe complications suffered in clinics with low case numbers will be successful in the near future, enforcing change by no later than then. We should prevent this, because of the heavy burdens for everybody involved.

Received: 04 April 2022

Accepted: 13 April 2022

Article published online:
25 August 2022

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