LJUBLJANA, Slovenia – The last two Slovenian surgeon who were eduacated for operating children with congenital heart failure left the program of children’s cardiac surgery in Ljubljana University Medical Centre (LUMC) two weeks ago. They do not trust the children’s cardiologists anymore and they can no longer cooperate with them.
“I don’t understand that a misunderstanding with cardiologists would be a reason for the resignation of those future heart surgeons from Ljubljana,” Marija Pfeifer, the expert director of LUMC said. “They didn’t get enough education at the time they worked in the program, because we, obviously, did not give them enough opportunity,” she added.
Nut Grapf: At this moment, there is no surgeon is Slovenia who could operate a child with a congenital heart failure. Problems have been present since 2004, after leaving the head of this activity, Miran Kosin, and three years later the Slovak cardiac surgeon Vladimír Soják. It was the moment when LUMC faced the challenge of successfully performing surgical services for Slovene children with congenital heart disease. The LUMC made an unusual deal with which the only child surgery, David Mishaly, was for surgery available only 3 to 6 days a month. This agreement has caused a number of difficulties in patient care, in re-operations, in-department relationships, reporting on surgery and training of new heart surgeons in the largest healthcare institution in Slovenia. Which led to one of the biggest scandals in Slovenia.
‘’This is one of the worst and ever-closing scandals in the LUMC ” said Petra Aleš, mother of 9-year old girl with a congenital heart failure and member of Society for Carfiovascular health of Slovenia. ‘’In 2007, when she had her first operation, I was happy to have her in Ljubljana. I did not think at all of another place abroad… they said that dr. Mishaly is one of the best,’’ she added.
Nut Grapf: The children’s cardiac program in Slovenia has been well documented and analyzed due to numerous controls. The public shook especially The Internal Audit Report of the activity of children’s heart surgery in Ljubljana for the period 2007-2014 which revealed a number of irregularities – that Israeli cardiac surgeon David Mishaly operated for several years without a medical license, for his work he received absurdly high fees, paid him through copyright contracts, he did not transfer his knowledge to the home surgeon.
Nut Grapf: ”Between 2007 and 2014 children were killed due to negligence and systemic mistakes” revealed the Internal Audit Report. Those who are responsible, despite the warnings of the profession, the reports of expert supervision, the anti-corruption commission and despite the conscientious objection of some doctors, did not act as they should.
Nut Grapf: Forward, not all operations were entered in the database of the competent European association. The Commission thus detected significant deviations from the international guidelines and standards that apply to cardiac surgery for children. Patient safety was “seriously compromised” between 2007 and 2014, they conclude in the report.
From 2007 to 2014 the mortality rate in 553 operations was 2.9%. The highest mortality rate in 2012 was 5.5%. The International Commission considered that four children who have died were treated controversial and that their death could be prevented.
”Examples of inadequate treatment have occurred in the past”, said expert director Pfeifer, and this year there was no complication or a malfunction. Asked how the report on the safety analysis of the death of a 37-days-old baby from 2015, which came to the media at the end of August this year, she commented that it was only ”part of the media movement.”
The general director of LUMC, Andraž Kopač, has a similar opinion, ”data on mortality in the program of children’s heart surgery show that the situation in the program is improving”, he said.
The Minister of Health, Milojka Kolar Celarc, who is, at least as politically inclined, likely to lose her mandate due to this affair, has already in June called the expert director and general manager of LUMC to resign, but without success. She determined that the LUMC Council must decide on their responsibility for the condition of childhood cardiology. At four sessions, and some of them canceled, the Council didn’t decide anything. Until last week, when the Council made a resolution on their dismissal.
Prime Minister Miro Cerar, with official statement appeared in the media, although many believe that he should have acted a long time ago.”We all see that the situation in the program of pediatric surgery is inadmissible and unacceptable, which shows that the LUMC leadership have no control, especially since, according to experts, they estimate that there are no problems. This is absolutely incredible,” he said at a government session last week.
Cerar also expects the LUMC ‘s public accounting is completed as soon as possible, “which led the management to cause great damage to its colleagues and distracted confidence in the functioning of the public health system”. He expects competent and trusted persons at the head of LUMC.
Nut Grapf: The government now decided, after the departure of the last two surgeons from the Children’s Heart Surgery program, to set up a center for the treatment of children and adults with congenital heart defects as an independent institution and not within the UKC. The management of the UKC still insists that the program is safe and that, in cooperation with Czech doctors, it will be improved, and that they allready signed a six-month contract.
”It’s not the best, it will never be the best, some parents will always be watching only narrowly, only for a personal story, but we must be aware that in the long run we are talking about 200 children a year, which should be considered quality” adds Petra Aleš, grateful her daughter is well today. The question that never has been resolved in this whole story is also, why the LUMC in the case of children being treated by foreign surgeons in Slovenia in the past, at the expense of the insurance company, didn’t want to send these children abroad to the same surgeon.
Some Facts:
When intervention needed, in the case of a small patient, any additional hour required for transportation may be critical. If we would like to have a professional program of child heart-surgery programe in LUMC they should employ at least two experienced surgeons. Slovenia should build a center in one or two years to meet international standards and carry out at least 250 operations a year. However, given the knowledge of the market and the trends in Slovenia and the region, the Commission finds it difficult to believe that this is possible in such a short period of time.
Of the 120 children with congenital heart defects who were operated in this program in 2016, four patients with complex, severe heart defects died. Two were operated at LUMC and two abroad.
Congenital heart disease (CHD) is the most common group of congenital malformations and accounts for more than one third of major congenital anomalies diagnosed prenatally or in infancy. The incidence if CHD is approximately 6-7/1000 newborns. Half of the patients have minor CHD that does not require treatment, or can be corrected later on in life.
Despite the improvement in diagnostics and treatment of CHD in the last few decades, CHD still cause significant morbidity and mortality, accounting for more than one third of deaths in children with congenital anomalies in the first year of life.
According to a contract signed with the Center for Child Heart Surgery in Prague, the first pediatric cardiac surgeon has already started to work in LUMC. By the end of the month, another experienced surgeon, who will carry out surgery, is expected to arrive.
The proposal of the new program is that surgeons will be here all week. Pfeifer believes, “that Slovene cardiac surgeon, who left two weeks ago, will still be involved in this program and may have thought about it when he sees that the program is now running safely, better organized.”
