Научная статья на тему 'Immediate and medium-long-term clinical and angiographic results of the use of bioresorbable vascular scaffold Absorb'

Immediate and medium-long-term clinical and angiographic results of the use of bioresorbable vascular scaffold Absorb Текст научной статьи по специальности «Клиническая медицина»

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BIORESORBABLE VASCULAR SCAFFOLD / ISCHEMIC HEART DISEASE

Аннотация научной статьи по клинической медицине, автор научной работы — Yuldashev Nabijon Primovich, Kurbanov Ravshanbek Davletovich

To study the safety and efficacy of the use of the second generation everolimus-releasing bioresorbable vascular scaffold Absorb in our real practice and the average long-term clinical results. The study involved 53 patients with various forms of ischemic heart disease who was undergone percutaneous coronary intervention with implantation of bioresorbable vascular sacaffold Absorb. The use of the Absorb BVS in clinical practice is associated with good immediate clinical and angiographic success rate and acceptable midterm clinical outcomes.

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Текст научной работы на тему «Immediate and medium-long-term clinical and angiographic results of the use of bioresorbable vascular scaffold Absorb»

Section l. Medical science

From this table it is also seen that a control group shunt system extreme pressure parameters have been set in all 4 patients, which was 23,5%.

We analyzed complications observed in the two groups of patients. The results are shown in table 2.

Table 2. - Complications after shunt surgeries compared in 2 groups of patients

Complications 1 -group; n=18 2 - group; n=17

Infection - 5 (29,4%)

Epileptic seizures 2 (11,1%) 4 (23,5%)

Dysfunction in a year 3 (8,6%) 5 (29,4%)

Hypo drainage 2 (11,1%) 4 (23,5%)

Hyper drainage - 17,6 (8%)

The data in table 2 allows to judge the reduction of the number of complications after shunt surgeries in patients of the main group as evidenced by the decrease in the number of dysfunctions in the study group (8.6%) compared with the control group — 29,4% and the number ofhypo drainage states 11,1% and 23,5% respectively. Statistical significance was confirmed by Spearman rank correlation (r=0,82).

It should be noted that initially poorly chosen option implantable shunt system creates unfavorable conditions for wound healing, and to a violation of its functionality.

Conclusions.

1) Established a direct link between the outcomes of operational activities and the accuracy of the determination craniospinal pressure in patients with encephalocele combines with hydrocephalus.

2) Application of methods for determining craniospinal pressure using " liquor dynamic test" program has reduced the violations of a shunt systems drainage dysfunctions in more than 2 times.

References:

1. Асадов Р. Н., Бельченко В. А., Притыко А. Г. Опыт хирургического лечения гигантских энцефалоцеле.//Сборник статей 3-й всероссийской конференции по детской нейрохирургии. - Казань, 8-10 июня 2011.

2. Асадов Р. Н. Одноэтапное комплексное лечение детей с врождёнными передними черепно-мозговыми грыжами//Сборник статей 3 -й всероссийской конференции по детской нейрохирургии. - Казань, 8-10 июня 2011.

3. Асадов Р. Н., Бельченко В. А., Притыко А. Г., Петров Ю. А. Хирургическое лечение передних черепно-мозговых грыж. Вопросы нейрохирургии. 2007.

4. Арутюнов Н. В., Петряйкин А. В., Корниенко В. Н. Изучение ликворотока на основе магнитно-резонансной томографии//Вопр. нейрохир. - 2000. - № 3.

5. Доманский Д. С., Белкин А. А. Влияние ликвородинамических нарушений на реализацию системы церебральной защиты//Мат-лы II Всероссийской конф. «Детская нейрохирургия». Екатеринбург. 27-29 июня 2007 г. - М., 2007.

6. Коммунаров В. В. Выбор параметров имплантируемой дренажной системы в лечении гидроцефалии: Автореф. дис.. канд. мед. наук. -СПб., 2003. -25 с.

7. Субботина М. В., Ларионов С. Н., Антошкина Е. П. Диагностика назоэтмоидальной мозговой грыжи у ребенка//Российская ринология. 2015;23 (2): 39-42.

8. Pudenz R. H. The surgical treatment of hydrocephalus//Surg. Neurol. - 1981.

9. Villarejo F. J. Atlas of pediatric Neurosurgical techniques//Basel; - New York: Karger. - 1985.

Yuldashev Nabijon Primovich, Prof. Kurbanov Ravshanbek Davletovich, «Republican specialized center of cardiology» JSC, Uzbekistan E-mail: [email protected]

Immediate and medium-long-term clinical and angiographic results of the use of bioresorbable vascular scaffold ABSORB

Abstract: To study the safety and efficacy of the use of the second generation everolimus-releasing bioresorbable vascular scaffold Absorb in our real practice and the average long-term clinical results. The study involved 53 patients with various forms of ischemic heart disease who was undergone percutaneous coronary intervention with implantation of bioresorbable vascular sacaffold Absorb. The use of the Absorb BVS in clinical practice is associated with good immediate clinical and angiographic success rate and acceptable midterm clinical outcomes.

Keywords: bioresorbable vascular scaffold, ischemic heart disease.

Since the discovery of coronary balloon angioplasty in 1977, despite the large number of achievements in the field of interventional cardiology biggest challenge remains the development of neo-intimal hyperplasia inside the stent, in-stent thrombosis and neoath-erosclerosis with the subsequent development of late and very late thrombosis [1; 2]. The constant presence of a metal prosthesis in the vessel wall causes a continual overlapping of lateral branches

at the level of branching vessels, prevents promising surgical re-

vascularization, worsens vasomotor function and vascular imaging stented segment during computed tomography [3]. In this connection, established bioresorbable vascular scaffold (BVS) Absorb (Abbott Vascular, Santa Clara, CA, USA) which is fully absorbable device for the temporary maintenance of the vascular wall and delivery of antiproliferative drugs Everolimus, which allows the vessel wall to recover without permanent presence of a metal stent [4]. In this study was to evaluate the success of the procedure, angiographic

Immediate and medium-long-term clinical and angiographic results of the use of bioresorbable vascular scaffold ABSORB

results and clinical outcomes in the medium to long-term period in patients with various forms of ischemic heart disease.

Material and Methods. The study included 53 patients undergoing percutaneous coronary intervention with BVS implantation. Baseline characteristics of patients and lesions are shown in Table № 1. Mean age was 51 ± 10 years, patients were predominantly male (90.5%) and in 20.7% of cases there were a diabetes mellitus. Stable angina was the indication for PCI in 37.7% of cases, and myocardial infarction (prescription> 1 week) in 50.9% and 11.4% unstable angina.

Table 1. - Baseline patient and lesion characteristics

Patients, n (%) 53

Age, yrs 51 (±11)

Male sex 48 (90.5)

Hypertension 43 (81.2)

Hyperlipidaemia 36 (67.9)

Diabetes mellitus 11 (20.7)

Previous myocardial infarction 6 (11.3)

EF LV 54.1 (±9.8)

Multivessel disease 6 (11.4)

Indication for PCI AMI (prescription> 1 week) 27 (50.9)

Stable angina 20 (37.7)

Unstable angina 6 (11.4)

Lesion, n (%) 54

Target lesion LAD 47 (87.0)

RCA 4 (7.4)

Cx 3 (5.6)

Lesion severity according to ACC/AHA A 7 (12.9)

B1 9 (16.7)

B2 12 (22.3)

C 26 (48.1)

Bifurcation 5 (9.3)

Calcification 6 (11.2)

Occlusion (<1 month) 8 (14.8)

Numbers are % or mean ±SD; EFLV: ejection fraction of left ventricle; PCI: percutaneous coronary intervention; AMI: acute myocardial infarction; LAD: left anterior descending; RCA: right coronary artery; Cx: circumflex; ACC/AHA: American college of cardiology/American heart association.

Six patients (11.4%) had multivessel disease. Most lesions (48.1%) were type C classification AHA/ACC cases with occlusion of the aged not more than 1 month and 8 bifurcation lesions was 5. General characteristics of treatments are given in table 2.

The PCI was performed as an elective procedure. Patients were pre-treated with dual antiplatelet therapy. Pre-dilation performed in 52 (96.2%) lesions. According to the instructions for pre-dilation balloon catheters used in short length than planned scaffold and 0.5 mm less than or equal to its diameter (ratio balloon/artery 0.7-1:1). After nitroglycerine (200 mcg), vessel size and lesion length were determined by quantitative coronary angiography (QCA). BVS implanted following the instructions for use: increasing pressure by 2 atm every five seconds up-to 12-14 atm, and post-dilatation with a shorter, non-compliant balloon at nominal pressure with a maximal increase of the balloon above scaffold size of 0.5 mm.

PCI for bifurcation lesions was performed as described in pro-visional-T with a single BVS and subsequent balloon dilatation of the lateral branches using compliance balloon catheter through the mesh at a low pressure CVD (<8 atm.) with the final optimization

of the BVS. In two cases due to the extent oflesions sequentially implanted two BVS by «marker to marker» technique.

Patients prescribed dual antiplatelet therapy for at least 12 months. Study population consisted of all patients undergoing PCI with implantation of BVS «Absorb» in the period from August 2014 to December 2015. The decision to implant BVS depended on the discretion of the operator, the presence of an appropriate frame size and the patient's consent. The study included patients with a wide spectrum of indications ranging from stable angina to acute myocardial infarction, and the diverse nature of de novo lesions.

Table 2. - Procedure characteristics

Variability 54

Total number of lesions 54

Lesions >20mm 23 (42.5)

One more scaffold implantation 6 (11.2)

Pre-dilation 52 (96.2)

Average diameter of balloon, mm 2.54±0.3

Average pressure of inflation, mm 12.8±1.6

Average time of exposition, sec 50.8±1.7

Post-dilation 54 (100)

Total number of scaffolds 61

Average length of scaffold, mm 24.4±8.3

Average diameter of scaffold, mm 3.3±0.2

Type of post-dilation balloons 54

Non-compliance balloon 45 (83.4)

Compliance balloon 9 (16.6)

Average diameter of balloon, mm 3.17±0.5

Average pressure of inflation, mm 14.3±4.4

Numbers are% or mean±SD.

Angiographic films were analyzed with appropriate software (QCA analysis, Philips, The Netherlands) by two of the researchers. The reference vessel diameter, the minimum diameter of the lumen (MDL) and percent diameter stenosis (% DS) were prepared for the target vessel before and after implantation of the scaffold. The «acute gain» was defined as the difference between the MDL before and after the procedure inside the scaffold. Angiographic success was defined in the presence final in-scaffold residual stenosis of <20% (by QCA) and TIMI-3 flow, without any complication. Success of the procedure was determined in the absence of significant clinical complications in the target vessel during hospitalization (cardiac death, myocardial infarction associated with the target artery, or the need for repeat revascularization of the target vessel, thrombosis of the scaffold). Under the immediate clinical success meant: the complete absence of symptoms of angina or decrease its symptoms for 2 or more functional classes of angina pectoris. Statistical data processing was carried out using MS Excel 2010 program.

Results and Discussion. Immediate angiographic and procedural success were achieved in 96.2% and 100% respectively. The immediate clinical success in 51 (96.2%) case had taken place. In 2 patients (3.8%) showed a reduction in angina class 1, which was due to the presence of atherosclerotic lesions in other segments of the coronary arteries. The immediate result is shown in table 3.

Basic analysis of the QCA was available for all lesions (table 4). Before the procedure, the average MDL was 0.35 mm, with an average 90.8% stenosis (DS). After the procedure average MDL was 3.1 mm, resulting in acute gain rate was 2,75mm.

Section 7. Medical science

Table 3. - Immediate and 30-day clinical and angiographic outcomes

53

Death and Myocardial infarction,% 0

Thrombosis,% 0

Residual stenosis >20%,% 0

Angiographic success,% 96,2

Clinical success,% 100

Procedural success,% 96,2

Table 4. - QCA outcomes before and after procedure

Before procedure After implantation under nominal pressure After post-dilatation P

Reference diameter of vessel 3.2±0.62 - 3.5±0.8 0.06

Minimal diameter of lumen 0.35±0.46 2.7±0.35 3.1±0.42 0.05

Diameter of ste-nosis,% 90.8±8.7 17.2±6.7 8.6±3.2 0.01

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Acute gain 2.75±0.51

Numbers are % or mean ±SD

Average long-term results of BVS implantation showed the following data (table 5): Median follow-up was 196 days (180-214). By the sixth month of observation were available to 100% of patients. It has been no cases of cardiac death. In one case (1.8%) due to self-canceling patient clopidogrel occurred later (three months after implantation) thrombosis of the BVS which subsequently led to the development of non-fatal myocardial infarction. Clinical success was observed in 49 of 53 patients (92.4%, p=0.0005). This was to maintain the achieved results and the clinical results of stress tests (bicycle exercise test) and also well dynamics of echocardiography. An increasing average left ventricular ejection fraction from 54.1±9.8 to 55.8±8.5% (p=0.1). In 4 (7.6%) patients revealed a refund clinics angina, Qpositive myocardial infarction occurred in 1 patient (1.8%). All patients with worsening clinical status in the long term repeat coronary angiography was performed, the results of which revealed the progression of atherosclerosis in other segments of the coronary arteries, restenosis signs of BVS have not been identified.

Table 5. - Medium-long-term clinical outcomes

53

Death, % 0

Thrombosis, % 1.8

Recurrent angina pectoris, % 7.4

Myocardial infarction, % 1.8

Clinical success, % 92.4

In the current study after implantation of BVS in population of CHD patients, including patients with a high risk and complex lesions, it has been received good angiographic (96.2%) and clinical (96.2%) success and acceptable intermediate clinical outcomes (the aggregate rate target vessel complication 1.8%). Our results showed that the percentage of angiographic success (96.2%) and

the results of the QCA is slightly lower than in cohort B ABSORB study [5]. This small difference is mainly due to the composition of our population, which included more complex lesions and patients with myocardial infarction, as well as the absence of intravascular imaging devices. General 30-day outcomes of our study were similar to published data on BVS Absorb [6; 7] where researchers found no cases of large cardiovascular events over the period of observation in the combined cohort of patients in relatively simple lesions in a cohort A. Large cardiovascular event rate for the six-month period was also comparable with the results Absorb study (3.6 vs. 3.0%). It noted one case of definite thrombosis of BVS. Thrombosis developed in three months after stop taking of clopidogrel. The incidence of target vessel complication was higher in our study compared with the cohort Absorb studies (1.8 vs 0%). This is due to the premature cancellation of antiplatelet therapy, which has led to the development of non-fatal myocardial infarction and scaffold thrombosis. Due to limited experience, the treatment of BVS thrombosis in our centre are not standardized, and in typical cases, the choice of strategy is at the discretion of the operator. According to the literature the treatment of thrombosis after implantation of scaffolds, especially the implantation of drug-eluting stents is also controversial. According to the literature in the short time period BVS may more prone to thrombosis compared to conventional metal stents, which is due to the thickness of beams (150mkm) with a greater surface area, which may take longer to cover the endothelial tissue [3]. Although in our experience small, cases of thrombosis associated with the procedure and the BVS was not observed. More research is needed to confirm the frequency greater thrombogenicity of BVS compared to conventional metal stents. Also, do not complete BVS apposition may also contribute to thrombosis. Incomplete BVS apposition can be avoided by improper preparation of lesion before scaffold implantation, adequate choice of scaffold's size, post-dilatation with high pressure balloon. According to the recommendations [8] for adequate lesion pre-dilatation must be used for balloon diameter is less than 0.5 mm on the proposed scaffold, as well as the need to use cutting balloons, rotational atherectomy and thrombectomy, which can support and improve the lesion preparing. We are also have found that delivery for platform sizes more difficult for complex lesions compared to the latest generation of stents in our experience. In calcified lesions and tortuosity of vessels for delivery to BVS required the use of additional support techniques.

Conclusions

1. Using the Absorb BVS in patients with various forms of ischemic heart disease are highly effective and safe method of treatment is accompanied by good immediate and medium to long-term results.

2. Delivery of the Absorb BVS is satisfactory, but still need to use the appropriate guide catheter, adequate pre-dilatation and if necessary a technique of soft hydrophilic wire deep intubation.

3. Implantation technique and receiving dual antiplatelet therapy is the key to achieve positive results in real practice. The case of the BVS thrombosis occurred after 3 months is associated with self-stopping of dual antiplatelet therapy.

4. Medium-long-term results of the study show that the BVS can be used in compliance with the basic principles of optimal implantation the Absorb BVS, despite the lack of imaging control during scaffold implantation.

References:

1. Garg S., Serruys P. W. Coronary stents: current status//J Am Coll Cardiol. - 2010. - Vol.56. - P. 1-42.

Open Vertebroplasty in surgical treatment of metastatic tumors of the spine

2. Nakazawa G., Otsuka F., Nakano M. et al. The pathology of neoatherosclerosis in human coronary implants bare-metal and drug-eluting stents//J Am Coll Cardiol. - 2011. - Vol. 57. - P. 1314-22.

3. Sousa J. E., Costa M. A., Abizaid A. et al. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study//Circulation. - 2001. - Vol. 103. - P. 192-195.

4. Wykrzykowska J. J., Onuma Y., Serruys P. W. Advances in stent drug delivery: the future is in bioabsorbable stents//Expert Opin Drug Deliv. - 2009. - Vol. 6. - P. 113-126.

5. Serruys P. W., Onuma Y, Dudek D. et al. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes//J Am Coll Cardiol. - 2011. - Vol. 58. - P. 1578-1588.

6. Diletti R., Karanasos A., Muramatsu T. et al. Everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with ST-segment elevationmyocardial infarction: BVS STEMI first study//Eur Heart J. - 2014. - Vol. 35. - P. 777-86.

7. Simsek C., Magro M., Onuma Y. et al. Procedural and clinical outcomes of the Absorb everolimus-eluting bioresorbable vascular scaffold: one-month results of the Bioresorbable vascular Scaffold Evaluated At Rotterdam Cardiology Hospitals (B-SEARCH)//Euro-Intervention. - 2014. - Vol. 10. - P. 236-240.

8. Serruys P. W., Onuma Y., Ormiston J. A. et al. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes//Circulation. - 2010. - Vol. 122. -P. 2301-2312.

Yuldashev Ravshan Muslimovich, Republican Scientific Centre of Neurosurgery of Ministry of Health of Republic of Uzbekistan,

Senior Researcher E-mail: [email protected]

Open Vertebroplasty in surgical treatment of metastatic tumors of the spine

Abstract: The treatment analysis of patients with pathological fractures of metastatic tumors of the spine in the thoracic and lumbar spine was performed. The results of surgical treatment were studied by using the method of internal stabilization and open vertebroplasty. The following benefits were highlighted: increased support ability of the vertebral height and preservation of his body, and improve the reliability of internal stabilization.

Keywords: tumor metastasis, spine, vertebroplasty, transpedicular stabilization, surgery.

The method of percutaneous (closed) vertebroplasty in treatment of patients with aggressive vertebral haemangiomas and spinal metastasis has proved its necessity and is widely used in treatment of the pathology. However, in surgical practice we often come across the situation, when neurological disorders and destruction of posterior wall of vertebral body do not let apply this method. In such situations, we have to make decompression of spinal canal and its content with removal of a part of metastatic tumor. But, while making posterior wall decompression and transpedicular stabilization, we do not always manage to fix damaged vertebral motion segment, to improve support ability ofvertebral column.

Purpose of the research — to conduct analysis of treatment of patients with pathological ruptures in haemangiomas and metastatic tumors in thoracic and lumbar spine, as well as to learn results of surgical treatment with use of intrinsic stabilization and open vertebroplasty method.

Materials and methods. Results of research and treatment of 12 patients with metastatic tumors and haemangiomas of thoracic and lumbar spine (4 patients with haemangiomas and 8 patients with metastasis) conducted within the period from 2009 to 2015 years at RUz MH RRCN. Age of the patients is between 36 to 55; 4 men and 8 women. Average age of the patients is 40. Clinical and neurological examination of all patients were made, the diagnosis is confirmed on the basis of instrumental examination (MRT, MSCT, Ultrasound investigation of abdominal cavity

and pelvic organs, pneumonography and others) of oncologist's decision. Careful selection of patients have been made — decom-pressive-stabilizing surgery and open vertebroplasty were made only in situations, when it was impossible to confine to percutaneous vertebroplasty, due to availability of long tract disorders as a result of partial compression of spinal cord, but hard destruction ofvertebral body was not reported at that (K. Tomita's classification, type 2,3, 2001y.). Results of the treatment were assessed based on the scale, assessing the dynamics of neurological disorders (ASIA) and dynamics of spinal axis recovery according to radiographic data.

Results. Localization of blastomas in region of vertebral column was as following: In thoracic spine — 4 (67%); in lumbar spine — 8 (33%).

Neurological signs, measured according to ASIA grading scale, are presented as follows. Patients of group B — 7 (58%), group C — 2 (17%), group D — 3 (25%). There are no patients of group A and E.

According to pain syndrome intensity (VAS scale) patients are divided as follows. 3 (25%) patients complained of inconsiderable pains (3-4 scores). 8 (67%) patients complained of moderate pain (5-7 scores). 1 (8%) patient with tumors of lumbar spine complained of severe pains (score 8 and over).

Table 1 presents assessment of spinal injury based on radiology examination.

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