Tomasz Niklewski

Randomized, Placebo-Controlled Study for Immunosuppressive Treatment of Inflammatory Dilated Cardiomyopathy Two-Year Follow-Up Results

Background—Previous studies have shown disappointing results for immunosuppressive treatment in patients with dilated cardiomyopathy. Therefore, we studied the effectiveness of such therapy in patients with HLA upregulation on biopsy. Methods and Results—Of 202 patients with dilated cardiomyopathy, 84 patients with increased HLA expression were randomized to receive either immunosuppression or placebo for 3 months; they were then followed for 2 years. After 2 years, there were no significant differences in the primary end point (a composite of death, heart transplantation, and hospital readmission) between the 2 study groups (22.8% for the immunosuppression group and 20.5% for the placebo). The secondary efficacy end point included changes in ejection fraction, end-diastolic diameter, end-diastolic volume, end-systolic volume and NYHA class; left ventricular ejection fraction increased significantly in the immunosuppression group compared with the placebo group (95% CI, 4.20 to 13.12;P <0.001) after 3 months of follow-up. The early favorable effects of immunosuppressive therapy on left ventricular volume, left ventricular diastolic dimension, and New York Heart Association class were also present. This improvement was maintained in the immunosuppression group at 2 years (ejection fraction: 95% CI, 6.94 to 19.04;P <0.001). In addition, on the basis of the protocol-specified definition of improvement, 71.8% patients in the immunosuppression group versus 20.9% patients in the placebo group met the criteria of improvement after 3 months (P <0.001). At the end of the follow-up period, 71.4% patients from the immunosuppression group versus 30.8% patients from the placebo group were improved (P =0.001). Conclusions—These data demonstrate a long-term benefit of immunosuppressive therapy in patients with dilated cardiomyopathy and HLA upregulation on biopsy specimens. Thus, restoration of immunosuppressive therapy for such patients should be considered.

Staged hybrid ablation for persistent and longstanding persistent atrial fibrillation effectively restores sinus rhythm in long-term observation

Introduction Hybrid ablation (HABL) of atrial fibrillation combining endoscopic, minimally invasive, closed chest epicardial ablation with endocardial CARTO-guided accuracy was introduced to overcome the limitations of current therapeutic options for patients with persistent (PSAF) and longstanding persistent atrial fibrillation (LSPAF). The purpose of this study was to evaluate the procedural safety and feasibility as well as effectiveness of HABL in patients with PSAF and LSPAF 1 year after the procedure. Material and methods The study is a single-center, prospective clinical registry. From 07/2009 to 12.2014, 90 patients with PSAF (n = 39) and LSPAF (n = 51), at the mean age of 54.8 ±9.8, in mean EHRA class 2.6, underwent HABL. 64.4% of patients had a history of prior cardioversion or catheter ablation. Thirteen patients had LVEF less than 35%. Mean AF duration was 4.5 ±3.7 years. Patients were scheduled for 3-, 6- and 12-month follow-up with 7-day Holter monitoring. Results At 6 months after the procedure 78% (54/69) of patients were in SR. At 12 months after the procedure 86% (59/69) were in SR and 62.3% (43/69) in SR and off class I/III antiarrhythmic drugs (AADs). Only 1% (1/69) of patients required a repeat ablation for atrial flutter. A significant decrease in LA dimension and an increase in LVEF were noted. Conclusions A combination of epicardial and endocardial RF ablation should be considered as a treatment option for patients with persistent and long-standing persistent atrial fibrillation as it is safe and effective in restoring sinus rhythm.

Angiographic and Intravascular Ultrasound Assessment of Immediate and 9-Month Efficacy of Percutaneous Transluminal Renal Artery Balloon Angioplasty with Subsequent Brachytherapy in Patients with Renovascular Hypertension

Background/Aim: Scarce data exist concerning the long-term effect of renal balloon angioplasty (PTRA) enhanced by intravascular γ-brachytherapy (IVBT) in patients with renovascular hypertension. The aim of this randomized study was to evaluate long-term outcome after PTRA with IVBT in patients with renal artery stenosis. Patients and Methods: 71 patients with renovascular hypertension were randomized into group I (PTRA + IVBT) or group II (PTRA). 9 patients who required stent implantation were excluded. Both baseline and 9-month follow-up quantitative computerized angiography and intravascular ultrasound (IVUS) analysis were performed to assess restenosis. During the 9-month follow-up, 3 patients died – 2 from group I and 1 from group II. Results: The restenosis rate was 16.1% in group I and 32.1% in group II. The 9-month lumen loss in angiography was 1.2 ± 0.7 and 1.7 ± 0.7 mm (p = 0.004) and the area loss (IVUS) was 6.5 ± 4.8 and 10.1 ± 5.6 mm2 in groups I and II, respectively (p = 0.01). eGFR increased both in group I (from 75 ± 22 to 84 ± 31 ml/min/1.73 m2; p < 0.001) and in group II (from 74 ± 23 to 77 ± 23 ml/min/1.73 m2; p = 0.04). Only the diastolic blood pressure in group I decreased significantly (65 ± 17 and 77 ± 18 mm Hg; p = 0.048). The rate of blood pressure normalization was low in both groups (6.1 and 6.9%). Conclusions: IVBT after PTRA with a self-centering source is a safe and effective method for prevention of restenosis in patients with renovascular hypertension.

Symetis Acurate Transapical Aortic Valve: the initial experience with a second generation of transcatheter aortic valve replacement device

BACKGROUND Transcatheter aortic valve replacement (TAVR) has proven to be a valuable alternative to conventional surgical aortic valve replacement in high risk and surgically in operable patients who suffer from severe symptomatic aortic stenosis. However, a significant number of complications, associated with both the learning curve and device specificity, have required attention and subsequent improvement. The Symetis transapical TAVR system is a self-positioning bioprosthesis composed of a non-coronary leaflet of surgical quality porcine tissue valve sewn into a self-expanding nitinol stent that iscovered with a PET-skirt. METHODS From June to September 2013 six patients have been operated on severe aortic stenosis using the new TAVR device. All patients have undergone critical assessment of a local Heart Team and have been disqualified from conventional AVR. Five were woman. Mean age was 82.3 ± 2.0 (mean LogEuroScore 23.9 ± 14.3). Four patients suffered from coronary artery disease - two had history of previous percutaneous coronary intervention with intracoronary stents, while the next two had history of coronary artery bypass grafting. Diabetes was frequent (n = 3) as well as chronic obstructive pulmonary disease (n = 4). Carotid artery disease was encountered in three patients similarly to atrial fibrillation. Mean left ventricular ejection fraction (LVEF) was 51.5 ± 11.8%, but one patient had suffered from low-flow-low-gradient aortic stenosis with LVEF of 29%. RESULTS The procedure was carried out successfully in all six cases. Two patients have received the valve sized L, three - M and one - S. Mean procedure time was 180 ± 19 min, mean cine 7.2 ± 1.2 min. Mean X-ray dose 930 ± 439 mGy, while mean volume of contrast given was 135 ± 61 mL. In all patients but one perivalvular leak (PVL) was not present. One patient had trace of PVL. Also, good LVEF was noted in all patients. Similar findings were obtained 30 days post procedure. No strokes, transient ischaemic attack or other cerebrovascular incidents were observed. CONCLUSIONS This brief clinical communication reports the first Polish experience with the second generation of TAVR device - the Symetis Acurate Transapical Aortic Valve. While it lacks large patient population and longer follow-up, it reveals that TAVR procedure can be performed safely, with minimal X-ray exposure time and contrast given and successfully - with almost nonexistent PVL and no cerebrovascular incidents or heart rhythm disturbances. Heart Team approach is vital, and transapical access should not be treated inferiorly, but rather as an equally appealing TAVR option.

Preoperative Echocardiography Examination of Right Ventricle Function in Patients Scheduled for LVAD Implantation Correlates with Postoperative Hemodynamic Examinations

BACKGROUND Left ventricular assist devices (LVAD) are used to treat heart failure. Preoperative prediction of RV function after LVAD implantation is crucial. Correlations were found between preoperative echo and RV function after LVAD implantation. MATERIAL AND METHODS We retrospectively reviewed 23 male patients (8 ischemic, 15 nonischemic cardiomyopathy) with LVAD implantation (17 HeartWare, 6 HeartMate II) at the Silesian Center for Heart Diseases from 1 January 2013 to 28 October 2014. Preoperative TTE data of RV function included RVFAC (fractional area change), TAPSE (tricuspid annulus plane systolic excursion), RV diameter (RV4), and RV/LV (right/left ventricle) ratio. Postoperative hemodynamic mean pulmonary pressure (mPAP), central venous pressure (CVP), cardiac output (CO), and cardiac index (CI) were measured and recorded every 2 h up to 10 days (1, 2, …120) and correlated. Study endpoints were mortality, discharge from ICU, and RV dysfunction. RESULTS There were no RV dysfunctions. Correlations of CO and CI with RV4 and RV/LV ratio were significantly positive at many time points, with TAPSE and FAC positive or negative. Correlations mPAP with RV4 were significantly positive: 1, 2, 3, 7, 8, 57, 58, 59. With RV/LV ratio positive: 44, 47, with TAPSE in 36. With FAC positive 11, 13-15, 22 and negative 57. Correlations CVP with RV4 were negative, with positive significance in 1, 52. With RV/LV ratio positively 52, 54, 56 and negative 71, 72, 73. With TAPSE were negative significantly: 30, 68. With FAC positive 11, 12, 13, 14 and negative: 68. CONCLUSIONS RV4 and RV/LV ratio before LVAD implantation are more predictive for postoperative RV function than RVFAC and TAPSE, probably because RVFAC and TAPSE are load-dependent.

Lipomatous hypertrophy of the interatrial septum: a rare cause of right ventricular impairment.

Abstract  We report a case of a 70‐year‐old woman admitted with symptoms of decompensated heart failure. Magnetic resonance imaging revealed lipomatous hypertrophy of the interatrial septum with partial upper right atrial inflow obstruction, partial obstruction of the right ventricular outflow tract, and excessive accumulation of adipose tissue in the pericardial space. The patient underwent excision of the septal lipomatous mass, which relieved the right ventricular outflow obstruction. (J Card Surg 2010;25:171‐174)

Intra-aortic balloon clamp for safe resternotomy in a patient with a giant aneurysm of sinuses of Valsalva

Despite advances in surgical techniques and postoperative medical management, the mortality rates for cardiac reoperations remain high. The risk is most commonly associated with failed resternotomy complicated by fatal injury to the myocardium or its structures. This short case report documents the first use of an endoluminal balloon occlusive device in order to prevent aneurysmal sack damage and coronary vessel injury in a patient with a giant aortic aneurysm after failed aortic surgery. The safe aortic occlusion allowed for closed-chest cardioplegia delivery and subsequent aortic unloading, thus facilitating a difficult but uneventful resternotomy.

The use of intraoperative epiaortic ultrasonography in monitoring patients over 75 years old treated with aortic valve replacement

Introduction Epiaortic ultrasound scanning (EAS) extended the use of ultrasound to the intraoperative diagnosis of aortic pathology. Surgical palpation of the ascending aorta underestimates the presence and severity of atherosclerotic plaques. Epiaortic ultrasound scanning has been used as an adjunct to transesophageal echocardiography (TEE) or as a primary direct diagnostic tool for imaging the ascending aorta as well as the aortic arch, which gained prominence as part of a multipronged intraoperative strategy to reduce atherosclerotic emboli. Aim To compare the epiaortic examination with transthoracic and transesophageal echo (transthoracic echocardiography (TTE) and TEE), X-ray, surgical intraoperative palpation, and postoperative neurological status. Material and methods The analyzed group consisted of 35 patients (mean age: 81.3 years) treated with aortic valve replacement (AVR), either alone (60%) or combined with coronary artery bypass grafting (CABG; 22.8%) or aortic aneurysm replacement (11.42%). In 2 patients, only CABG was performed because intraoperatively reevaluated strategy. Thierteen patients have got a history of diabetes, 10 chronic renal failure and 3 of cerebral stroke. Results In more than 80% of patients, positive EAS results had an influence on the choice of aortic clamping site and in 50% of patients on the site of cannulation. Female sex, peripheral vascular disease, history of previous stroke, and calcifications in the ascending aorta in TTE have significant predictive value for recognizing atherosclerotic changes in EAS and the risk of postoperative neurological complications in octogenarians treated with AVR. Conclusions Epiaortic ultrasound scanning imaging is superior to TTE and manual palpation in the detection and localization of ascending atherosclerosis. This technique should be introduced as a standard perioperative examination in older patients at risk of neurological complications.

Impact of CoreValve size selection based on multi-slice computed tomography on paravalvular leak after transcatheter aortic valve implantation

BACKGROUND Paravalvular leak (PVL) has significant impact on long-term outcomes in patients after transcatheter aortic valve implantation (TAVI). This study sought to determine whether multi-slice computed tomography (MSCT)-guided valve selection reduces PVL after CoreValve implantation. METHODS The analysis encompassed 69 patients implanted with CoreValve and were divided into two groups. In Group I (30 patients), valve selection was based on standard procedures, in Group II (39 patients), on MSCT measurements. Paravalvular leak was assessed with angiography and echocardiography. RESULTS Multi-slice computed tomography results influenced a change of decision as to the size of the implanted valve in 12 (30.9%) patients in Group II and would have caused the decision to change in 9 (37.5%) patients in Group I. The degree of oversizing in Group I and II was 12.8% ± ± 7.6% vs. 18.6% ± 5.1% (p = 0.0006), respectively. The oversizing among the patients with leak degree of 0-1 and ≥ 2 was 18.1% ± 6.0% and 12.8% ± 7.4% (p = 0.0036). Angiographic assessment indicated post-procedural PVL ≥ 2 in 50% of patients in Group I and 20.5% in Group II (p = 0.01), while echocardiographic assessment indicated the same in 73.3% of patients in Group I and 45.6% in Group II (p = 0.0136). The composite endpoint occurred in 26.6% (8/30) patients in Group I vs. 5.1% (2/39) patients in Group II (p = 0.0118). CONCLUSIONS Selecting the CoreValve device based on MSCT resulted in smaller rates of PVL and less frequent composite endpoint. In 1/3 of patients MSCT led to a change of the valve size. The degree of oversizing had a significant impact on PVL.

The use of a new hybrid stentgraft for the repair of extensive thoracic aortic aneurysms with the frozen elephant trunk method - first Polish experiences.

The frozen elephant trunk (FET) technique is a modification of the traditional elephant trunk method, which was introduced by Borst in 1983 in order to treat extensive thoracic aortic aneurysms. The crux of the new method is the different type of aortic prosthesis, consisting of a Dacron part (with or without branches leading to the arterial vessels which exit the aortic arch) and a port for extracorporeal circulation with a self-expanding nitinol stentgraft. This combination enables a complete one-stage treatment of the pathologies within the arch and the proximal segment of the descending aorta; moreover, it facilitates the performance of a two-stage hybrid treatment of extensive thoracic aortic aneurysms involving a significant part of the descending aorta. This article presents the cases of four patients with extensive aortic disease, who were implanted with Thoraflex prostheses (Vascutek, Scotland).