Wojciech Zajdel

Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet-covered embolic prevention stent system.

AIMS Our aim was to determine (1) periprocedural and 30-day clinical safety and efficacy of the CGuard MicroNet-covered embolic prevention carotid stent system (MN-EPS) in routine use for unselected carotid stenosis (CS) patients undergoing CAS, as well as (2) feasibility of MN-EPS post-dilatation optimisation to minimise residual stenosis after CAS. METHODS AND RESULTS This was a non-industry-funded, prospective academic study in all-referrals-tracked symptomatic and asymptomatic CS. In asymptomatic lesions, intervention was mandated only in case of increased stroke risk CS features. There was independent neurologist evaluation before CAS, at 48 hours and 30 days. There was external source data verification, angiographic core lab, and statistical analysis. Over 11 months, 108 referrals were recommended by the NeuroVascular Team for revascularisation: 101 (51-86 years, 55 symptomatic, evolving stroke in nine) underwent 106 (100% MN-EPS use) neuroprotection device-assisted (46% proximal, 54% distal) CAS; CEA was performed in seven. MN-EPS device success was 99.1%. Angiographic diameter stenosis was reduced from 83±9% to 6.7±5% (p<0.001). No MN-EPS foreshortening/elongation occurred (30 mm long was 29.82±0.68 mm; 40 mm long was 39.89±0.59 mm). The periprocedural death/major stroke/MI rate was 0%. One event, with no change in NIHSS or modified Rankin Scale and no clinical sequel, was adjudicated by the clinical events committee as minor stroke (0.9%). By 30 days there were no new events (0%). CONCLUSIONS These increased risk consecutive patient data (1) indicate safety and efficacy of routine MN-EPS use in achieving endovascular reconstruction across all-comer CS lesion subsets, and (2) are consistent with MN-EPS protection against cerebral events extending throughout the stent healing period.

Evolution of myocardial perfusion during primary angioplasty in spontaneously reperfused infarct-related artery: impact on long-term clinical outcomes and left ventricular function recovery.

BACKGROUND TIMI myocardial perfusion grade (TMPG) reflects the integrity of microvasculature in ST-elevation myocardial infarction (STEMI). We sought to investigate whether TMPG evolution during primary angioplasty (pPCI) in spontaneously reperfused STEMI patients might predict long-term outcomes. METHODS 392 patients with TIMI-3 flow before pPCI were analyzed. According to pre- and post-pPCI TMPG four reperfusion patterns were created: A. TMPG deterioration from grade 2/3 to 0/1 after pPCI (n = 55, 14.0%), B. TMPG-0/1 before and after pPCI (n = 111, 28.3%), C. TMPG improvement from grade 0/1 to 2/3 (n = 52, 13.3%), D. TMPG-2/3 before and after pPCI (n = 174, 44.4%). 30-day and 1-year mortality and heart failure requiring hospitalization (HF-hosp) were recorded. Left ventricular ejection fraction (LVEF) was measured at first day (1D) and after 6 months (6M). RESULTS 1D-LVEF was similar in A-D groups. After 6M, LVEF improved in pattern D (7.5 ± 5.4%, p<0.01) and C (3.7 ± 3.4%, p < 0.05), deteriorated in pattern A (5.2 ± 3.9%, p<0.01) and did not change in pattern B. 6M-LVEF increased (p < 0.001) and frequency of 1-year HF-hosp decreased (p < 0.001) in stepwise fashion among A-D patterns. A 30-day mortality rate for A-D patterns was 9.1%, 2.7%, 1.9% and 0%, respectively (p < 0.001). 1-year mortality was 16.3%, 7.2%, 5.8% and 0.6%, respectively (p < 0.001). By multivariate analysis (c-index = 0.79), TMPG evolution was independent predictor of 1-year mortality (HR = 2.5, 95%CI 1.3-4.0, p = 0.006). CONCLUSIONS Maintaining TMPG-2/3 or improving TMPG-0/1 through pPCI in STEMI implies LV function recovery and good long-term survival. In contrast, substantial deterioration of TMPG is associated with lack of LV function recovery, and the highest mortality rate.

Denervation of nerve terminals in renal arteries: one-year follow-up of interventional treatment of arterial hypertension

BACKGROUND Arterial hypertension is the most common cardiovascular system disease, affecting nearly one billion people worldwide. Despite the widespread use of antihypertensive medications, in some groups of patients an optimal blood pressure (BP) cannot be achieved. AIM To assess BP reduction in patients with resistant hypertension after a catheter-based renal sympathetic denervation procedure and to report vascular and kidney safety in one-year follow-up. METHODS Twenty eight patients with diagnosed resistant hypertension (median age 52.02 years, range 42-72) underwent percutaneous catheter-based renal denervation of nerve terminals in renal arteries. Arterial angiography and procedure of ablation was performed by Symplicity catheters and generator provided by Ardian (currently Medtronic Inc., USA). RESULTS Mean BP value before ablation was [mm Hg]: systolic 176.6, diastolic 100.28 and pulse pressure 73.4. After the procedure, reductions in the value of BP were reported [mm Hg]: systolic 154.8/152.54; diastolic 90.2/89.8, pulse pressure 64.66/62.73, respectively in nine-month and one-year follow-up. All results were statistically significant. No complications during one year observation were observed. CONCLUSIONS Percutaneous renal artery ablation procedure effectively reduces systolic BP, diastolic BP, and pulse pressure. No vascular or renal complications in any of the patients were observed. The results of a Polish research group showed no significant differences compared to the results obtained in the international studies Symplicity I and Symplicity II.

Denervation (ablation) of nerve terminalis in renal arteries: early results of interventional treatment of arterial hypertension in Poland

BACKGROUND Arterial hypertension is one of the main causes of cardiovascular disease morbidity and overall mortality. AIM To report the single centre experiences with changes in arterial blood pressure (BP) in patients after intra-arterial application of radiofrequency (RF) energy to cause renal sympathetic efferent and somatic afferent nerve and report vascular and kidney safety in a six month follow up. METHODS Twenty-eight patients, with hypertension despite medical therapy (median age 52.02 years, range 42-72 years) consented to therapeutic renal nerve ablation. SIMPLICITY RF catheters and generator provided by Ardian (currently Medtronic Inc., USA) were used to perform renal artery angiography and ablation. RESULTS The mean BP at baseline, and after one month, three months and six months were measured [mm Hg]: systolic 176.6; 162.3 (p = 0.004); 150.6 (p < 0.001); 147.2 (p < 0.001); diastolic 100.2; 90.3 (p < 0.001); 91.79 (p = 0.03); 88.5 (p < 0.001); pulse pressure 76.57; 75.18 (p = NS); 65.80 (p < 0.001); 62.15 (p < 0.001). Neither procedure-related nor therapy-related complications were reported in the six month follow up. CONCLUSIONS In our cohort of patients, intra-arterial renal nerve denervation was not associated with either vascular or renal complications out to six months. Nerve ablation of renal arteries led to significant reduction of mean values of arterial systolic, diastolic BP and significant reduction of pulse pressure. The Polish experience is not significantly different compared to that reported in the Symplicity I and Symplicity II international cohorts. The long term durability of this therapy and its application to earlier stages of hypertension or other disease states will require further investigation.

Adaptation of global hemostasis to therapeutic hypothermia in patients with out-of-hospital cardiac arrest: Thromboelastography study

BACKGROUND The use of mild therapeutic hypothermia (MTH) in patients after out-of-hospital cardiac arrest (OHCA) who are undergoing primary percutaneous coronary intervention (pPCI) can protect patients from thromboembolic complications. The aim of the study was to evaluate the adaptive mecha- nisms of the coagulation system in MTH-treated comatose OHCA survivors. METHODS Twenty one comatose OHCA survivors with acute coronary syndrome undergoing imme- diate pPCI were treated with MTH. Quantitative and qualitative analyses of physical clot properties were performed using thromboelastography (TEG). Two analysis time points were proposed: 1) during MTH with in vitro rewarming conditions (37°C) and 2) after restoration of normothermia (NT) under normal (37°C) and in vitro cooling conditions (32°C). RESULTS During MTH compared to NT, reaction time (R) was lengthened, clot kinetic parameter (a) was significantly reduced, but no effect on clot strength (MA) was observed. Finally, the coagulation index (CI) was significantly reduced with clot fibrinolysis attenuated during MTH. The clot lysis time (CLT) was shortened, and clot stability (LY60) was lower compared with those values during NT. In vitro cooling generally influenced clot kinetics and reduced clot stability after treatment. CONCLUSIONS Thromboelastography is a useful method for evaluation of coagulation system dysfunc- tion in OHCA survivors undergoing MTH. Coagulation impairment in hypothermia was associated with a reduced rate of clot formation, increased weakness of clot strength, and disturbances of fibrinoly- sis. Blood sample analyses performed at 32°C during MTH, instead of the standard 37°C, seems to enhance the accuracy of the evaluation of coagulation impairment in hypothermia.

Clinical factors predicting blood pressure reduction after catheter-based renal denervation

Introduction Renal denervation (RD) can lead to a significant and sustained decrease in mean values of arterial blood pressure (BP). However, there is still a subset of patients without a significant BP drop after RD (non-responders). Aim To compare characteristics of RD responders to RD non-responders and to identify the clinical predictors of BP reduction. Material and methods Thirty-one patients with diagnosed resistant hypertension underwent RD. Three years after RD the analysis of BP reduction was performed in regard to the baseline patient characteristics. Results After 3 years’ follow-up a 10% or more reduction of systolic baseline BP was observed in 74% of patients. Ten percent or more reduction of diastolic baseline BP was observed in 71% of patients. Among responders we observed the following risk factors: hypercholesterolemia in 70%, body mass index (BMI) > 30 kg/m2 in 55%, diabetes mellitus in 35%, current smoking in 5%. Comorbidity included coronary artery disease (CAD) in 30%, cardiomyopathy in 10%, chronic obstructive pulmonary disease (COPD) in 10%, renal insufficiency in 10%, and ventricular arrhythmia in 5%. Among non-responders we observed the following risk factors: hypercholesterolemia in 38%, diabetes mellitus type 2 in 38% and BMI > 30 kg/m2 in 86%. Comorbidity included CAD in 50% and cardiomyopathy in 13% of patients. Conclusions A 10% reduction of systolic baseline BP was observed in 74% of patients 3 years after renal denervation. Clinical factors like COPD, chronic kidney disease 3a, female sex and hypercholesterolemia increase the chances of effective reduction of BP.

Blood pressure reduction in patients with accessory renal arteries and bilateral single renal arteries after catheter-based renal denervation: prospective study with 3-year follow-up.

INTRODUCTION Catheter‑based renal denervation (RD) is an effective treatment leading to a significant reduction of systolic and diastolic blood pressure (BP) in patients with resistant hypertension. OBJECTIVES The aim of this prospective study was to assess the BP-lowering and pulse pressure (PP)- lowering effects in patients with accessory and bilateral single renal arteries after catheter‑based RD during a 3‑year follow‑up. PATIENTS AND METHODS The study included 31 patients with diagnosed resistant hypertension. Patients were classified into 2 groups: group 1 included patients with accessory renal arteries, and group 2, with bilateral single renal arteries. The BP and PP reduction levels were measured before the procedure and at 6, 12, 24, and 36 months after the procedure. RESULTS All procedures were successful. In group 1, mean systolic BP, diastolic BP, and PP at baseline were 172.7 mm Hg, 98.9 mm Hg, and 74.4 mm Hg, respectively. Systolic BP, diastolic BP, and PP reduction levels were, respectively, -26.9, 19.2, and 7.5 at 6 months; -33.3, 16.1, and 16.4 at 12 months; -29.2, 14, and 18.2 at 24 months; and -28.6, 13.6, and 13.7 at 36 months. In group 2, mean systolic BP, diastolic BP, and PP at baseline were 175.6 mm Hg, 100.1 mm Hg, and 75.5 mm Hg, respectively. Systolic BP, diastolic BP, and PP reduction levels were, respectively, -26, 10.5, and 15.5 at 6 months; -22, 8.9, and 13 at 12 months; -28, 12.4, and 15.6 at 24 months; and -24.6, 14.97, and 9.2 at 36 months. Significant reductions were observed for systolic BP in group 1 and for PP and systolic and diastolic BP in group 2. CONCLUSIONS RD successfully reduced systolic BP in patients with resistant hypertension and accessory renal arteries. PP reduction after RD in patients with accessory renal arteries was less pronounced than in patients with bilateral single renal arteries.

Renal artery sympathetic nerve radiofrequency denervation

BACKGROUND Arterial hypertension is one of the most common chronic diseases in the western world, affecting more than 25% of the adult population. AIM The aim of this study was to assess changes in arterial blood pressure (BP) levels in hypertensive patients, after ablation of nerve terminals in renal arteries, using radiofrequency energy during 24 months of follow-up. METHODS Thirty-two patients with diagnosed resistant hypertension (20 men and 12 women) underwent percutaneous catheter-based renal denervation of nerve terminals in renal artery walls. Mean BP value before ablation was [mm Hg]: systolic 174.92, diastolic 99.73 and pulse pressure 75.19. After procedure reduction value of BP was reported [mm Hg]: systolic 146.78; diastolic 87.14, pulse pressure 59.64 at 24-month follow-up (p < 0.05 for all). RESULTS 30% of patients had systolic BP ≤ 140 mm Hg, 67% had diastolic BP ≤ 90 mm Hg, and optimum BP values ≤ 140/90 mm Hg were observed in 30% of patients. CONCLUSIONS In our cohort of patients, percutaneous renal artery ablation procedure effectively reduces systolic, diastolic BP and pulse pressure. No adverse events during 24 months of follow-up were noted. These results were comparable with available data from SIMPLICITY I and II trials.

Determinants of long-term outcome in patients after percutaneous stent-assisted management of symptomatic subclavian or innominate artery stenosis or occlusion

AIMS Incidence and determinants of restenosis and adverse events after endovascular management (PTA±stent) of the subclavian/innominate artery (SA/IA) stenosis/occlusion remain unclear due to the relatively short-term follow-up or limited size of prior studies. This large-scale, long-term prospective study investigated safety, efficacy, and prognosis after SA/IA PTA±stent. METHODS AND RESULTS The study involved 411 consecutive patients with symptomatic SA/IA stenosis/ occlusion; 393 were followed annually after successful PTA±stent for up to 16 (minimum one) years. Primary outcomes were freedom from restenosis and MACCE (cardiovascular death, myocardial infarction, stroke). Angiographic success rate was 99.7% in stenoses and 76.1% in occlusions. The incidence of any periprocedural complication was 4.4% (serious - 1.2%). Symptoms of limb ischaemia, vertebrobasilar insufficiency or angina resolved in 79.1%, decreased in 19.6%. Freedom from restenosis was 82.6% and 77.9% whereas freedom from MACCE was 86.6% and 78.3% at five and 10 years, respectively. MACCE determinants (HR; 95% CI) were previous myocardial infarction (5.36; 2.9-9.91), ischaemic stroke (2.03; 1.12-3.66), hs-CRP (1.04; 1.02-1.07), concurrent atherosclerosis (1.35; 1.00-1.82). Restenosis determinants were implantation of ≥2 stents (2.65; 1.23-5.72), stent diameter (0.45; 0.34-0.59), hs-CRP (1.06; 1.02-1.1), WBC (1.2; 1.07-1.35), age (0.97; 0.94-0.99), concurrent carotid or vertebral disease (1.85; 1.07-3.18), IA intervention (2.28; 1.08-4.84). CONCLUSIONS This study established long-term durability of stent-assisted PTA of symptomatic SA/IA disease and identified risk factors for restenosis and long-term MACCE. Patients at increased risk might benefit from targeted, intensified prevention measures.

TCT-796 Highly Calcific Carotid Lesions Endovascular Revascularization Using a Novel, Dual-layer Carotid Stent System CGuardTM: Analysis from the PARADIGM Study

TCT-796 Highly Calcific Carotid Lesions Endovascular Revascularization Using a Novel, Dual-layer Carotid Stent System CGuardTM: Analysis from the PARADIGM Study Adam Mazurek, Mariusz Trystuła, Jacek Jąkała, Andrzej Brzychczy, Anna Borraty nska, Agata Le sniak-Sobelga, Małgorzata Urba nczyk, R. Paweł Bany s, Wojciech Zajdel, Klaudia Proniewska, Lukasz Partyka, Krzysztof Zmudka, Piotr Podolec, Piotr Musialek Department od Cardiac and Vascular Diseases, John Paul II ND Hospital, Krakow, Poland; School of Medicine, University of California, Irvine; UC Davis; Kurume-univaersity; John Paul II Hospital, Krakow, Poland; Al Qassimi Hospital; Clinical centre of Serbia; John Paul II Hospital, Krakow, Poland; Clinical Dept. of Interventional Cardiology, John Paul II Hospital, Krakow, Poland; Krakow Cardiovascular Research Institute, Krakow, Poland; University Hospital Krakow, Krakow, Poland; John Paul II Hospital in Krakow, Krakow, Poland; Clinical Center of Serbia; John Paul II Hospital, Krakow, Poland