Intracoronary Hemodynamic Effects of Pressure‐Controlled Intermittent Coronary Sinus Occlusion (PICSO): Results from the First‐In‐Man Prepare PICSO Study

Background: Myocardial reperfusion is frequently suboptimal after ST‐segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI). Using a balloon‐tipped catheter positioned in the coronary sinus (CS), pressure‐controlled intermittent coronary sinus occlusion (PICSO) results in an intermittent obstruction of coronary venous outflow of the left anterior descending artery (LAD), and may improve myocardial perfusion by augmenting redistribution of blood to the border zone of ischemic myocardium. We sought to document the intracoronary hemodynamic effects of PICSO during PCI. Methods: We included 15 patients with stable angina scheduled for PCI of the LAD. Balloon occlusion of the LAD was performed twice, once with and once without PICSO and lasting maximally 3 minutes each, to document the effect of PICSO on CS pressure and LAD wedge pressure. Results: Catheter delivery was successful in all patients. The study protocol could not be conducted in 5 patients due to initial calibration difficulties (n = 3), a pressure wire problem (n = 1), and a vagal response at the start of the procedure (n = 1). In the remaining 10 patients, CS occlusion caused a marked increase in mean CS pressure (4.1 ± 7.3 mmHg vs. 22.0 ± 12.6 mmHg; P < 0.001) and CS pulse pressure (4.3 ± 0.8 mmHg vs. 36.1 ± 6.3 mmHg; P < 0.001). Concomitantly, mean distal LAD wedge pressure and wedge pulse pressure increased (32.4 ± 12.2 mmHg vs. 35.5 ± 12.6 mmHg; P < 0.001 and 39.1 ± 27.2 mmHg vs. 45.9 ± 26.0 mmHg; P < 0.001, respectively). At 30 day follow‐up, no device‐related events occurred. Conclusions: PICSO safely augments CS pressure, thereby increasing LAD coronary wedge pressure. These findings support further evaluation of PICSO in the setting of STEMI. (J Interven Cardiol 2012;25:549–556)     

A Comparative Study of Bivalirudin Plus Clopidogrel versus Bivalirudin Plus Prasugrel in Primary Angioplasty Using Propensity Score Matching

Introduction and Objectives

In primary angioplasty, bivalirudin is superior to treatment with heparin plus glycoprotein inhibitors for reducing cardiovascular events, although bivalirudin increases the risk of stent thrombosis. Our hypothesis is that the use of prasugrel plus bivalirudin in primary angioplasty would reduce stent thrombosis and cardiovascular events.

Method

Consecutive patients with acute ST‐segment elevation myocardial infarction who were treated by primary angioplasty within 12 hours of the onset of symptoms received bivalirudin plus clopidogrel (Group A) or bivalirudin plus prasugrel (Group B). We compared the groups using propensity score matching. The combined end‐point was cardiac death, thrombosis, acute myocardial infarction, and cerebrovascular accident at 30 days.

Results

We assessed 168 patients. The approach was preferentially radial (95.7%). No differences in baseline characteristics were observed between Groups A (n = 70) and B (n = 70). The total mortality and rate of major bleeding complications at 30 days were 0% for both of the groups. The rate of acute and subacute thrombosis was 4.3% in Group A and 0% in Group B (P = 0.08). We observed an increased rate of events in Group A (5.7%) versus Group B (0%) (P = 0.042).

Conclusions

The administration of bivalirudin plus prasugrel in primary percutaneous coronary intervention reduces cardiovascular effects compared to bivalirudin plus clopidogrel without increasing major bleeding complications during the first 30 days following primary angioplasty performed with a preferentially radial approach. (J Interven Cardiol 2013;26:463‐469)

     

RELIABILITY AND VALIDITY OF THE DUTCH VERSION OF THE INVENTORY OF TRAUMATIC GRIEF (ITG)

The psychometric properties of the Dutch version of the Inventory of Traumatic Grief (ITG) were investigated in two studies with bereaved adults who had suffered the loss of a first-degree relative. In Study 1, exploratory factor analysis indicated that the items of the ITG clustered together into one underlying factor. In addition, the internal consistency of the ITG and its short-term temporal stability were found to be high. In Study 2 it was found that the ITG exhibited adequate discriminative, concurrent, and construct validity. Furthermore, an ITG cutoff score for a diagnosis of traumatic grief was determined, with a sensitivity of 86% and a specificity of 76%, providing evidence in favor of the predictive validity of the ITG.     

Malignancy: Adjuvant Radiotherapy to Initial Bulky Disease in Patients with Advanced Stage Hodgkin's Disease

To determine if the use of adjuvant radiotherapy to sites of initial bulky disease and adequate modern chemotherapy in patients with advanced stages (IIIB and IV) Hodgkin's disease could improve duration of remission and overall survival. Patients previously untreated with pathologically documented advanced stages Hodgkin's disease were randomly assigned to received chemotherapy alone with EBVD regimen (epirubicin, bleomycin, vinblastine and dacarbazine): 56 patients or combined therapy: The same chemotherapy regimen following by adjuvant radiotherapy (35 Gy) to sites of initial bulky disease (tumor mass >7 cm diamenter): 54 patients. Five year overall survival rates were 88% (48 patients) and 60% (34 patients) from combined therapy compared to chemotherapy alone respectively (p < 01) (95% confidence interval (CI): for the difference 18% to 39%). Five-year failure free survival were 83% and 50% respectively (p < 01) (95% CI for difference: 22% to 35%). Toxicity was moderate and well tolerate. No death-related treatment were observed. After a median follow-up of 66 months, no second solid neoplasmas or acute leukemia has been observed. The use of adjuvant radiotherapy to sites of initial bulky disease following the use of modern chemotherapy in patients with advanced stages Hodgkin's disease improve outcome with increase in failure free survival and overall survival, with moderate toxicity. More randomized clinical trials are warranted to define this therapeutic approach.