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Abstrak :
ABSTRAK
Latar belakang: External Counter Pulsation (ECP) dapat diaplikasikan sebagai pilihan terapi pada pasien dengan angina refrakter yang tidak adekuat dikendalikan dengan terapi medis, angioplasti perkutan (IPK) ataupun bedah pintas arteri koroner (BPAK). Hasil bervariasi masih diperoleh pada perbaikan fraksi ejeksi ventrikel kiri pada pasien yang menjalani ECP. Metode 2D-Speckle Tracking Echocardiography (2D-STE) dianggap lebih unggul menilai perbaikan klinis, namun hingga kini belum ada penelitian yang mengevaluasi mekanikal ventrikel kiri dengan menggunakan 2D-STE pada pasien yang menjalani protokol standar ECP (35 sesi).

Tujuan: Mengetahui perubahan mekanik ventrikel kiri sesudah dilakukan 35 protokol standar ECP dibandingkan dengan kontrol/sham pada pasien angina refrakter yang tidak ideal menjalani revaskularisasi konvensional (IPK/BPAK).

Metode: Pasien dengan angina refrakter yang tidak dapat dilakukan revaskularisasi lebih lanjut secara konvensional (IPK/BPAK) dirandomisasi menjadi 2 kelompok: kelompok terapi standar ECP (300 mmHg) dan kelompok placebo/sham (75 mmHg). Terapi standar ECP diberikan selama 35 sesi, durasi 1 jam/hari/sesi, selama 5 hari/minggu, selama 7 minggu. Data 2D-STE mencakup strain longitudinal dan post systolic index (PSI) diambil sebelum dan sesudah terapi (dengan double-blind).

Hasil: Terdapat 46 subjek ikut serta dalam penelitian dan tidak ada subjek yang mengalami drop-out. Tiga pasien dieksklusi karena kualitas ekokardiografi sub-optimal. Dua puluh dua subjek disertakan dalam Grup Terapi ECP dan 21 subjek dalam Grup Kontrol (sham). Karakteristik dasar strain homogen sebelum dilakukan perlakuan baik secara global (Grup Terapi 12,42±4,55 vs Grup Sham 12,00±4,92; p 0,774) maupun secara segmental/regional (Grup Terapi 12,63 (0,01-25,16) vs Grup Sham 12,43 (0,01-27,20); p 0,570). Setelah perlakuan tidak didapatkan perbedaan bermakna secara statistik antar kelompok pada parameter mekanik ventrikel kiri baik secara global (p 0,535) maupun regional (p 0,434). Parameter PSI mengalami perbaikan pada grup Terapi (p 0,049) dan segmen dengan PSI≥20% cenderung mengalami perbaikan strain longitudinal pada grup Terapi dibanding grup Sham (p 0,042).

Kesimpulan: Terapi ECP sebanyak 35 sesi tidak memberikan perbaikan mekanik ventrikel kiri secara global maupun regional/segmental pada pasien angina refrakter yang tidak ideal menjalani revaskularisasi konvensional (IPK/BPAK) dibanding sham.

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ABSTRACT
Background: External Counterpulsation (ECP) can be applied as a therapeutic option in patients with debilitating refractory angina inadequately controlled by medical therapy, percutaneous angioplasty (PCI), or coronary artery bypass surgery (CABG). Varied results are still obtained in the improvement of the left ventricular ejection fraction in patients undergoing ECP. The 2D-Speckle Tracking Echocardiography (2D-STE) method is considered superior in assessing clinical improvement, but there has been no study evaluating mechanical parameters of the left ventricle using 2D-STE in patients undergoing the standard ECP protocol (35 sessions).

Objective: To determine the effect of ECP on left ventricular mechanical parameters changes after performing 35 ECP standard protocols compared with sham (control) in patients with refractory angina who are not ideal for conventional revascularization (PCI/CABG).

Methods: We conducted a double-blind randomized control trial. Patients with refractory angina who could not be further revascularized conventionally (PCI/CABG) were randomized into 2 groups: the ECP group (300 mmHg) and the Sham group (75 mmHg). ECP standard therapy was given for 35 sessions, duration of 1 hour/day/session, for 5 days/week, for 7 weeks. 2D-STE data including strain and post systolic index (PSI) were obtained before and after therapy.

Results: There were 46 subjects included in the study without any drop-out. Three patients were excluded due to suboptimal echocardiographic images. Twenty-two subjects were included in the ECP group and 21 subjects into the sham group. A homogenous baseline strain was found either globally (ECP group 12.42 ± 4.55 vs Sham group 12.00±4.92; P=0.774) or segmentally/regionally (ECP group 12.63 (0.01-25.16) vs the Sham group 12.43 (0.01-27.20); P=0.570). After treatment, there was no statistically significant improvement between groups in the mechanical function of the left ventricle both globally (P=0.535) or regionally/segmentally (P=0.434). There were improvements in the PSI parameters found in the ECP group (P=0.049) and segments with PSI ≥20% tended to improve longitudinal strains in the Therapy group compared to the Sham group (p 0.042).

Conclusion: 35 sessions of ECP therapy did not improve the global nor regional/segmental left ventricular mechanical parameters in patients with refractory angina who were not ideally suited for conventional revascularization (PCI/CABG) compared to Sham.

Abstrak :
Latar Belakang : External counterpulsation (ECP) ditunjukkan dapat mengurangi gejala angina dan memperbaiki kualitas hidup pasien penyakit jantung koroner (PJK) dengan angina refrakter. Efek protektif jangka panjang ini dipikirkan merupakan efek dari peningkatan pulsatile shear stress pada endotel vaskular sehingga terjadi perbaikan pada fungsi endotel. Dalam proses ini, sekelompok miRNA berfungsi meregulasi ekspresi gen dan dipengaruhi oleh shear stress, diantaranya adalah miR-92a yang bersifat proatherosklerosis. Tujuan : Mengetahui pengaruh ECP terhadap kadar miR-92a di plasma pada pasien PJK dengan angina refrakter. Metode : Sebanyak 50 pasien PJK dan angina refrakter direkrut dan diacak ke salah satu dari kelompok terapi ECP atau sham (1:1), dan menjalani 35 sesi yang berdurasi 1 jam tiap sesi. Terapi sham serupa dengan terapi ECP namun memberikan tekanan yang jauh lebih rendah. Level miR-92a di sirkulasi diukur di plasma darah sebelum dan sesudah selesai seluruh terapi, kemudian besar perubahan pada kedua kelompok dibandingkan. Hubungan antara keluaran klinis seperti keluhan angina, kapasitas fisik dan ejection fraction (EF) ventrikel kiri dengan kadar miR-92a juga dinilai. Hasil : miR-92a di plasma meningkat bermakna pada kelompok ECP [+5.1 (+4.2 s.d +6.4) menjadi +5.9 (+4.8 s.d +6.4), p value <0.001] dan sham [+5.2 (+4.1 s.d +9.4) menjadi +5.6 (+4.8 s.d +6.3), p value 0.008]. Besar perubahan dan fold changes cenderung lebih besar pada kelompok ECP namun tidak berbeda bermakna secara statistik dibandingkan kelompok sham. Kadar miR-92a post intervensi berkorelasi signifikan dengan rasio diastolik/sistolik selama terapi dan perbaikan EF pasca intervensi. Selain itu, perubahan miR-92a berkorelasi positif dengan perbaikan kapasitas fisik. ......Background : Noninvasive modality External counterpulsation (ECP) can improve angina frequency and exercise capacity in refractory angina (RA) patients. The long term benefit is thought to be the result of increase in shear stress on vascular endothelial cells resulting in improvement of endothelial dysfunction. In this process, a group of miRNA regulating gene expression in relation to shear stress is called flow-sensitive miRNA, among them is miR-92a. Aim : To evaluate ECP effect on plasma miR-92a level in RA patients. Method : Fifty subjects with RA were enrolled and randomized to either one of ECP or sham therapy (1:1 randomization). Each therapy session was one hour, for a total of 35 sessions. As a control, sham gave same sensation as ECP but with lower pressure. Plasma miR-92a level was measured before and after therapy and delta changes was compared between group. Secondary clinical outcome such as angina class, physical capacity and left ventricle Ejection Fraction (EF) were also measured and correlated with miR-92a level. Result : Plasma miR-92a level increased in both treatment groups [in ECP group +5.1 (+4.2 to +6.4) to +5.9 (+4.8 to +6.4), p value <0.001, in sham group +5.2 (4.+1 to 9.4) to +5.6 (+4.8 to +6.3), p value =0.008]. There was higher delta increase and fold changes in ECP group, however the difference did not reach statistically significant. miR-92a level post intervention correlated significantly with Diastolic/Systolic ratio during intervention and improvement in ejection fraction (EF) post intervention. Moreover, changes in miR- 92a correlated positively with improvement in physical capacity. Conclusion : ECP did not cause significant different increase of miR-92a compared to sham.