Georg Fröhlich

A Randomized Clinical Trial to Evaluate the Safety and Efficacy of a Percutaneous Left Ventricular Assist Device Versus Intra-Aortic Balloon Pumping for Treatment of Cardiogenic Shock Caused by Myocardial Infarction

OBJECTIVES The aim of this study was to test whether the left ventricular assist device (LVAD) Impella LP2.5 (Abiomed Europe GmbH, Aachen, Germany) provides superior hemodynamic support compared with the intra-aortic balloon pump (IABP). BACKGROUND Cardiogenic shock caused by left ventricular failure is associated with high mortality in patients with acute myocardial infarction (AMI). An LVAD may help to bridge patients to recovery from left ventricular failure. METHODS In a prospective, randomized study, 26 patients with cardiogenic shock were studied. The primary end point was the change of the cardiac index (CI) from baseline to 30 min after implantation. Secondary end points included lactic acidosis, hemolysis, and mortality after 30 days. RESULTS In 25 patients the allocated device (n = 13 IABP, n = 12 Impella LP2.5) could be safely placed. One patient died before implantation. The CI after 30 min of support was significantly increased in patients with the Impella LP2.5 compared with patients with IABP (Impella: DeltaCI = 0.49 +/- 0.46 l/min/m(2); IABP: DeltaCI = 0.11 +/- 0.31 l/min/m(2); p = 0.02). Overall 30-day mortality was 46% in both groups. CONCLUSIONS In patients presenting with cardiogenic shock caused by AMI, the use of a percutaneously placed LVAD (Impella LP 2.5) is feasible and safe, and provides superior hemodynamic support compared with standard treatment using an intra-aortic balloon pump. (Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock [ISAR-SHOCK]; NCT00417378).

Real‐time optical coherence tomography coregistration with angiography in percutaneous coronary intervention–impact on physician decision‐making: The OPTICO‐integration study

Intracoronary optical coherence tomography (OCT) imaging allows for high‐resolution characterization of coronary lesions. Difficulties in matching cross‐sectional OCT‐images with angiographic lesion localization may limit optimal clinical utilization. We sought to prospectively assess the impact of a novel system of real‐time OCT coregistration with angiography (ACR) on physician decision‐making during percutaneous coronary interventions (PCI).

Thrombus aspiration in STEMI revisited: impact on coronary microcirculation?

In this issue of Open Heart , Hoole et al 1 present the IMPACT trial. The authors investigate the effect of thrombus aspiration (TA) on changes in microvascular function during primary percutaneous coronary intervention (PPCI) for ST elevation myocardial infarction (STEMI). However, no difference between the TA group and the control group receiving balloon angioplasty first line could be verified. This is a timely topic indeed, since the impact of TA on coronary microcirculation was an important rationale to suggest prognostic benefits in patients with STEMI in the past. Early data from smaller and medium-sized randomised controlled trials (RCT) fuelled substantial enthusiasm about the concept of coronary thrombectomy with a view to reduce the thrombus burden, and avoid distal embolisation and consecutive ‘no reflow’ in PPCI.2 ,3 Of note, ‘no reflow’ following PPCI has been observed frequently in this patient cohort.4 This phenomenon has been closely associated with microvascular obstruction and increased myocardial infarct size, with worse adverse clinical outcome.5 Similarly, dislodged debris from the culprit lesion, consisting of conglomerates of platelets and neutrophil granulocytes, may congest the microvasculature and deteriorate the ‘no reflow’.6 This is also a feature of the reperfusion injury (RI), which occurs after restoration of blood flow in the infarcted vessel.6 Notably, this RI has been estimated to account for up to 50% of the final infarct size, and efforts to mitigate the RI and ‘no reflow’ appear therefore as an appealing therapeutic approach. …

FD-OCT and IVUS for detection of incomplete stent apposition in heavily calcified vessels: novel insights

In the present issue of Open Heart , Gudmundsdottir and colleagues compare two intracoronary imaging modalities, intravascular ultrasound (IVUS) and FD-optical coherence tomography (FD-OCT), in patients undergoing complex percutaneous coronary intervention (PCI) with rotablation for calcific coronary lesions. In particular, this study sought to detect incomplete stent apposition (ISA) using these different imaging modalities. ISA may play a role in the risk of target vessel failure, for example, stent thrombosis.1 Intracoronary imaging has become widely available with the advent of IVUS in the early 1990s.2 IVUS-derived images with an axial resolution down to 150 µm have given novel insights into the clinical evolution of coronary artery disease and plaque composition.3 This technology was rapidly embraced by the interventional cardiology community, mainly to assess coronary lesions of intermediate significance in larger coronary arteries, to size the stent diameter or to monitor optimal stent deployment and exclude coronary dissections post-stenting.2 While this new intracoronary imaging fuelled enthusiasm, to date, limited data exist to demonstrate that IVUS-guided PCI translates into a superior clinical outcome with respect to incomplete stent apposition (table 1). However, a large observational analysis comparing IVUS-guided against angiography-guided PCI suggested that IVUS guidance was associated with a reduction in stent thrombosis, myocardial infarction and major adverse cardiac events within …

Performance of One- Compared With Two-Catheter Concepts in Transradial Coronary Angiography (from the Randomized Use of Different Diagnostic Catheters-Radial-Trial)

The Use of Different Diagnostic Catheters-Radial-Trial sought to compare the safety and efficacy of one-catheter concepts (OCC) using Tiger II or BLK catheters with two-catheter concepts (TCC) using standard Judkins catheters for transradial coronary angiography. A total of 300 patients planed for coronary angiography were enrolled into this single-center, single-blinded trial. Patients were randomized in a 2:1 ratio to either OCC by Tiger II (n = 100) and BLK (n = 100) or TCC by Judkins (n = 100) catheters. Primary end point was time required to perform a complete coronary angiography. Coronary angiography duration was 603 ± 29 seconds and 552 ± 26 sec in the OCC and the TCC groups (p = 0.052). Fluoroscopy time was longer in the OCC (408 ± 28 sec) as compared with the TCC group (258 ± 28 sec, p = 0.009) and the amount of contrast volume used significantly higher (98 ± 5 ml vs 67 ± 4 ml, p < 0.001). Crossover rates were increased in the OCC as compared with the TCC group (37% vs 4%, p < 0.001). These effects were observed irrespective of OCC catheter type. In conclusion, this study demonstrates that OCC do not reduce angiography time, but are associated with an increased amount of contrast volume and longer fluoroscopy time as compared with TCC.

Effect of Physical Disability on Mortality in Elderly Patients of ≥80 Years of Age Undergoing Percutaneous Coronary Intervention

Functional decrease has been linked with adverse events in different clinical contexts. The predictive role of activity of daily living status as assessed by the Barthel index (BI) in elderly patients who underwent percutaneous coronary intervention (PCI) has not been investigated, yet. In this study, a total of 616 patients (≥80 years) who underwent PCI between January 2009 and December 2014 and with available activity of daily living data on admission were stratified according to BI (low BI <85, intermediate BI 85 to 95, high BI 100). The primary end point was all-cause mortality at a total follow-up of 442 days (interquartile range 47 to 1243). Of the 616 patients, 178 (29%), 128 (21%), and 310 (50%) were in the low, the intermediate, and the high BI groups, respectively. All-cause mortality was 10%, 13%, and 5% in the low, the intermediate, and the high BI groups, respectively (log-rank p <0.001). Belonging to the high BI group was associated with a reduced risk of all-cause mortality (hazard ratio 0.35, 95% confidence interval 0.18 to 0.69, p = 0.002), and associations remained significant after multivariable adjustments (adjusted hazard ratio 0.34, 95% confidence interval 0.13 to 0.93, p = 0.04). Functional capacity was identified as independent predictor of survival in a large cohort of patients who underwent PCI. In conclusion, activities of daily living should be incorporated into the risk stratification of elderly patients with coronary artery disease.

Myokard-Revaskularisation – die neue europäische Leitlinie

The updated 2014 ESC guidelines on myocardial revascularization did indeed impact on current practice. Some of the most important changes are summarized in this review. Importantly, the recommendation for dual antiplatelet therapy after stenting in stable patients was reduced to 6 months. Also, a more liberal use of PCI in left main stem disease was proposed by the ESC guideline committee.