News Article | May 16, 2017
After Paolo Macchiarini’s star fell in Sweden, the Italian surgeon still had a place to shine: Russia. The Karolinska Institute (KI) in Stockholm fired him in March 2016 for multiple ethical violations, including "breach of KI’s fundamental values" and "scientific negligence." But Russia had long showered Macchiarini with funding and opportunities to perform his experimental surgeries to implant artificial tracheas, and it allowed him to stay. Now, a year later, his Russian refuge has ended as well. On 30 March, it became clear that the Russian Science Foundation (RSF) would not renew its funding for Macchiarini’s work, which now focuses on the esophagus rather than the trachea. The decision came 9 days after Nature Communications retracted a paper by Macchiarini that documented successful esophagus transplantations in rats. Minutes of a meeting made public last week show that Kazan Federal University (KFU), Macchiarini’s current employer, decided to end his research project there on 20 April, effectively firing him. “They have probably realized that it’s all based on nothing but hot air,” says Pierre Delaere of the University of Leuven in Belgium, one of the first to criticize Macchiarini’s work. Yet despite a passionate plea by four Swedish doctors who blew the whistle on Macchiarini’s work at Karolinska in 2014, Russian authorities appear to have no plans to launch a misconduct investigation of his work in Russia. Macchiarini has not said publicly what he plans to do next, and did not respond to an interview request from Science. Once considered a pioneer of regenerative surgery, Macchiarini aimed to give patients whose tracheas had been damaged a new windpipe. “Seeded” with stem cells, it was supposed to grow into a new, fully functional organ. (He initially used donor tracheas as a basis, but later switched to an artificial scaffold.) But he has been accused of painting a false picture of his patients in scientific papers, several of which have been retracted; operating without ethical approval; and lying on his CV. At least six of the eight artificial trachea recipients have died. In Sweden, where the case has plunged science into a crisis, investigations continue into allegations including involuntary manslaughter. Macchiarini’s parallel life in Russia began in February 2010, when he conducted a master class in regenerative surgery at the invitation of Mikhail Batin, president of the Science for Life Extension Foundation (SLEF), which aims to make “radical extension of life a Russian national goal,” according to its website. Eight months later, Macchiarini agreed to do a trachea transplantation, in tandem with surgeon Vladimir Parshin at the Boris Petrovsky Research National Center for Surgery in Moscow. Glowing television coverage quickly made Macchiarini a scientific star. SLEF then helped secure a $2.6 million “megagrant” from the Russian government, aimed at luring foreign talent, and additional funding from Kuban State Medical University (KSMU), a well-known medical school in Krasnodar, some 1400 kilometers south of Moscow. Macchiarini carried out four artificial trachea transplantations at Krasnodar Regional Hospital No. 1. In 2014, his work was featured in a permanent exhibition about Russia’s scientific and technological prowess at the Polytechnic Museum in Moscow. But dramatic footage of one Russian patient eventually triggered Macchiarini’s downfall in Sweden. Experimenten, a three-part documentary broadcast in January 2016, claimed that the patient, Yulia Tuulik, didn’t have a life-threatening condition; her trachea had been damaged in a car accident, but she was able to breathe through a stoma. Macchiarini and his colleagues presented Tuulik’s operation as a medical triumph at a press conference. But her trachea later collapsed, and she received a replacement, which didn’t work well either; she died in 2014. Two other Krasnodar patients have died as well; the only survivor had his transplant removed. After Experimenten aired in Sweden and a few publications about Macchiarini appeared in the Russian press, an audit by the Federal Service for Supervision of Healthcare of the Krasnodar hospital revealed that he had operated without a Russian medical license and had filed no documentation about the materials in the artificial windpipe with the state register. The hospital was ordered to correct those violations, but no sanctions were imposed. Macchiarini’s defenders have interpreted the criticism as an attack on Russia; a January article on a portal for Russian doctors, for instance, suggested that Macchiarini had come under fire in Sweden because of the success of the laboratory he founded in Krasnodar. “I’m … outraged not so much by criticism of myself, as by criticism of the conditions and standards of research in Russia,” Macchiarini himself told the website Lenta.ru. Even before Macchiarini’s megagrant ended, RSF provided him with a new grant for some $1 million annually to develop a tissue-engineered esophagus and test it in nonhuman primates. In 2016, Macchiarini asked RSF to transfer the grant from KSMU to KFU, 800 kilometers east of Moscow in Tatarstan. Since then he has worked out of the limelight. But KFU soon grew uneasy. In a December 2016 newspaper interview, KFU Rector Ilshat Gafurov said that Macchiarini would not carry out operations at KFU as long as he did not have the required papers, and would not even see patients. According to RSF’s website, Macchiarini has given 10 baboons small pieces of artificial esophagus at the Research Institute of Medical Primatology in Sochi, a city on the Black Sea; all supposedly recovered. Data from the experiment have not been published, but KFU “can guarantee that the results, whatever they may be, will reflect the real state of affairs, will be truthful,” a spokesperson for the university says. Last December, the four original whistle-blowers in Sweden sent several Russian government agencies a 57-page petition asking for a criminal investigation of Macchiarini because he “systematically falsified, omitted or glorified” data from his operations in Sweden to obtain an ethical approval for his work in Krasnodar. None of the agencies has responded, says one of the authors, Matthias Corbascio of Karolinska University Hospital. Corbascio welcomes Macchiarini’s dismissal but says it should only be the beginning: “We hope that a police investigation is initiated in Russia and that Macchiarini will face criminal charges.” (A spokesperson for the Russian health ministry says it has never received the document.) Macchiarini’s Russian patients or their relatives could sue the Krasnodar hospital, says Alexander Saversky, president of the Russian League for the Protection of Patients, if there is strong suspicion that the operations did more harm than good. So far, nobody has done that. There’s no point, Natalia Tuulik, Yulia’s mother, told a newspaper: “The court will not return my daughter to me.”
Trembach N.,Kuban State Medical University |
Zabolotskikh I.,Kuban State Medical University
Respiratory Physiology and Neurobiology | Year: 2017
The aim of the study was to determine the feasibility of using a breath-holding test in assessing the sensitivity of the peripheral chemoreflex compared with the single-breath carbon dioxide test. The study involved 48 healthy volunteers between the ages of 18–29 years. The breath-holding test was performed followed by the single-breath carbon dioxide test on the next day. A month after the first tests, these tests were repeated to evaluate their reproducibility The coefficient of variability in the single-breath carbon dioxide test ranged from 0 to 32% with a mean of 10 ± 7%. The mean coefficient of variability of the breath-holding test was 6 ± 4% (0–19%). A significant inverse correlation between the results of the two tests was noted following analysis (r = −0.82, p < 0.05). Conclusion A breath-holding test after deep inspiration reflects the sensitivity of the peripheral chemoreflex as defined by the single-breath carbon dioxide test in healthy subjects. © 2016 The Authors
Pokrovskii V.M.,Kuban State Medical University |
Polischuk L.V.,Kuban State Medical University
Journal of Integrative Neuroscience | Year: 2012
This study describes methods of volitional management of heart rhythms and proves that it is possible by means of management of its operations, subject to arbitrary control, which also has a strong functional connection to the center of the heart rhythm formation in the brain. Experiments demonstrate that it is possible for arbitrary changes in the heart rhythm to be made through conscious control of the breathing rhythm, and even a short-term cardiac arrest by means of contracting abdominal muscles. We postulate that the management of human heart rhythm is indirectly regulated through arbitrary controlled operations. The present article describes and analyzes ways that enable a human to consciously and purposefully manage the frequency of heart contractions. Common principles of arbitrary management of the heart rhythm in humans are uncovered through analysis. © 2012 Imperial College Press.
Zaytseva N.,Kuban State Medical University
World Neurosurgery | Year: 2010
Background: Previous research has suggested that increases in length of stay and hospital cost in patients undergoing spine surgery can be due to comorbidities, especially diabetes mellitus. To study how endocrine comorbidities impact spine surgery cost, we conducted the further analysis. Methods: We reviewed the charts of 787 patients operated between 2005 and 2008 and their treatment cost. Patients underwent one of three of the most common types of spine surgery: lumbar microdiskectomy (N = 237), anterior cervical decompression and fusion (N = 339), and lumbar decompression and fusion (N = 211). Patients were 14 to 92 years of age (mean 54.5 years), nearly equally divided by gender and mostly white. Demographics, body mass index, and comorbidities were studied versus length of stay and hospital charges. Data were analyzed using the Mann-Whitney and Pearson χ2 tests with the help of the SPSS v16 software. Results: Among the 653 patients who had their glycosylated hemoglobin (HbA1c) level measured, 32.5% had an HbA1c level <6.1% and 4.3% had high HbA1c level and hypothyroidism. These two comorbidities increased with age. Cost analysis showed that in the lumbar decompression and fusion group, length of stay and hospital cost significantly increased with these comorbidities. Without HbA1c elevation or hypothyroidism, the average length of stay for lumbar decompression and fusion patients was 5 days. This increased to 6 days with hypothyroidism. With both comorbidities the average length of stay increased to 8 days (P < .01). Regarding hospital cost, without these comorbidities the average was approximately $52,449. With elevated HbA1c the cost increased to $56,176 and with hypothyroidism to $63,278 (P < .01 and P < .05, respectively). When both comorbidities were present the average hospital cost was $71,352. It was also noted that 89.7% of the patients with hypothyroidism were women. Cost and length of stay increased with age in the female lumbar decompression and fusion group. In addition, there was a surge in length of stay and cost in the <70-year-old female group with hypothyroidism undergoing anterior cervical decompression and fusion. Conclusions: HbA1c elevation and hypothyroidism have an additive effect on hospital cost in lumbar decompression and fusion female patients. The finding of a surge in hospital cost parameters in elderly female hypothyroid patients undergoing surgery on their cervical spine needs more investigation. © 2010 Elsevier Inc. All rights reserved.
Zaytseva N.V.,Kuban State Medical University
Journal of Clinical Neuroscience | Year: 2010
Depression is the most common psychiatric illness in the USA and is commonly diagnosed in patients with chronic back pain. We investigated the use of mood-altering medications among spine surgery candidates and the relationship with opioid use and cost of care. We retrospectively reviewed the charts of 578 spine surgery patients who underwent surgery during 2005 to 2007 and their hospital charges. Patients were divided by type of spine surgery as follows: 154 lumbar microdiscectomies (LMD), 297 anterior cervical decompression and fusions (ACDF) and 127 lumbar decompression and fusions (LDF). We found that 25.4% of spine surgery candidates were on antidepressants, 9.3% on anxiolytics, and 41.3% on opioids were. More precisely, 26.6% of LMD, 24.6% of ACDF and 26% of LDF patients were on antidepressants; 9.1% of LMD, 7.1% of ACDF, and 15% of LDF patients were on anxiolytics; and 47.4% of LMD, 36% of ACDF, and 46.5% of LDF patients were on opioids. Of all patients, 16.8% were on two or three types of these medications. Significantly more antidepressants were used by females in the ACDF and LDF groups and more opioids were used by African Americans in the LDF group. There were significant differences (p < 0.05) in the length of stay and hospital cost between patients on antidepressants and those not on antidepressants in the LDF group, especially among females. Opioids are the most commonly used psychoactive drugs among chronic back pain and spine surgery candidates followed by antidepressants and anxiolytics. Screening for antidepressant use among spine surgery patients seems reasonable on the preoperative visit. This would help adjust antidepressant medications following surgery as depression might resolve in response to pain improvement. If antidepressant medications were initially prescribed to treat pain; they also might need to be tapered off postoperatively to correspond with new pain levels. The relationship of antidepressants with increased hospital charges in this category of patients requires further investigation. © 2009 Elsevier Ltd. All rights reserved.
Zabolotskikh I.,Kuban State Medical University |
Trembach N.,Kuban State Medical University
BMC Anesthesiology | Year: 2015
Background: The increased intracranial pressure can significantly complicate the perioperative period in major abdominal surgery, increasing the risk of complications, the length of recovery from the surgery, worsening the outcome. Epidural anesthesia has become a routine component of abdominal surgery, but its use in patients with increased intracranial pressure remains controversial. The goal of the study was to evaluate the safety and efficacy of epidural anesthesia, according to monitoring of intracranial pressure in patients with increased intracranial pressure. Methods: The study includes 65 surgical patients who were routinely undergone the major abdominal surgery under combined epidural/general anesthesia. Depending on the initial ICP all patients were divided into 2 groups: 1 (N group) - patients with the normal intracranial pressure (≤12 mm Hg, n = 35) and 2 (E group) - patients with the elevated intracranial pressure (ICP > 12 mm Hg, n = 30). During the surgery we evaluated ICP, blood pressure, cerebral perfusion pressure (CPP). The parameters of recovery from anesthesia and the effectiveness of postoperative analgesia were also assessed. Results: In N group ICP remained stable. In E group ICP decreased during anesthesia, the overall decline was 40 % at the end of the operation (from 15 to 9 mm Hg (P <0.05)). The correction of MAP with vasopressors to maintain normal CPP was required mainly in patients with increased ICP (70 % vs. 45 %, p <0.05). CPP declined by 19 % in N group. In E group the CPP reduction was 23 %, and then it remained stable at 60 mm Hg. No significant differences in time of the recovery of consciousness, effectiveness of postoperative analgesia and complications between patients with initially normal levels of ICP and patients with ICH were noted. Conclusions: The combination of general and epidural anesthesia is safe and effective in patients with increased intracranial pressure undergoing elective abdominal surgery under the condition of maintaining the arterial pressure. Its use is not associated with the increase in intracranial pressure during the anesthesia, but it needs an intraoperative monitoring of ICP in order to prevent CPP reduction. © Zabolotskikh and Trembach.; licensee BioMed Central.
Kanorsky S.G.,Kuban State Medical University
Kardiologiya | Year: 2013
According to results of large clinical studies angiotensin II receptor blockers (ARB) and aliskiren do not lower risk of cardiovascular complications and mortality in wide spectrum of clinical conditions and are able to worsen renal outcomes. It is expedient to prefer inhibitors of angiotensin converting enzyme in particular Perindopril over ARB in the treatment of patients with arterial hypertension taking into consideration differences in effect on mortality. Fixed perindopril/indapamide combination provides achievement of target arterial pressure in many patients with uncontrolled hypertension, has good tolerability, is metabolically neutral, and possesses high organoprotective properties.
Oranskiy S.P.,Kuban State Medical University |
Yeliseyeva L.N.,Kuban State Medical University
Clinical and Experimental Rheumatology | Year: 2014
Objective: To investigate urine excretion of nephrin in patients with proteinuric nephropathies associated with rheumatoid arthritis (RA). Methods: We enrolled in the study 42 patients with seropositive RA and proteinuria, the control group (20 persons) was formed from healthy blood donors, the comparison group (23 persons) was formed from RA patients without proteinuria. Kidney biopsy was performed in 26 patients (glomerulonephritis was diagnosed in 14 patients, AA-amyloidosis in 7 patients and tubulointerstitial nephritis in 5 patients). Results: Urine nephrin concentration in patients with RA and proteinuria was 6.2 (3.0; 8.8) ng/ml and significantly differed in its levels both in controls - 3.6 (2.4; 5.3) ng/ml (p=0.03) and RA patients without proteinuria - 3.2 (2.1; 5.1) ng/ ml (p=0.015) group. In RA patients with proteinuria, we found a positive correlation between urine nephrin and protein concentrations (r=0.4; p=0.04). Urine nephrin levels in patients of the glomerulonephritis - 7.3 (5.9; 9.2) and amyloidosis groups - 6.9 (3.9; 9.8) ng/ml were higher than in the controls (p=0.001; p=0.04) and in the group of patients without proteinuria (p=0.005; p=0.03). In the patients with tubulointerstitial nephritis urine nephrin concentration did not differ significantly with the values in both the control and the RA patients without proteinuria groups. Conclusion: According to our data, proteinuria in the overall cohort of patients with seropositive RA is associated with increased levels of urine nephrin excretion, the highest levels of nephrin excretion were registered in patients with glomerulonephritis and amyloidosis. © Clinical and Experimental Rheumatology 2014.
Kanorskii S.G.,Kuban State Medical University
Kardiologiya | Year: 2015
The article presents the results of new experimental and clinical studies of selective inhibitor of lf-channel, ivabradine confirming the feasibility of its use in coronary heart disease and chronic heart failure. We discuss some of the pleiotropic effects of ivabradine. Ivabradine may be useful in therapeutic areas outside those where it has previously demonstrated clinical efficacy.
Kanorsky S.G.,Kuban State Medical University
Kardiologiya | Year: 2015
Of 10 261 patients with type 2 diabetes who survived to the end of a randomized ADVANCE trial 83% were included in the ADVANCE-ON project for observation for 6 years. The difference in the level of blood pressure which had been achieved during 4.5 years of within trial treatment with fixed perindopril/indapamide combination quickly vanished but significant decrease of total and cardiovascular mortality in the group of patients treated with this combination for 4.5 years was sustained during 6 years of post-trial follow-up. The results can be related to gradually weakening protective effect of perindopril/indapamide combination on cardiovascular system, and are indicative of the expedience of long-term use of this antihypertensive therapy for maximal lowering of mortality of patients with diabetes. i.