Acute and long-term results of bifurcation stenting (from the Coroflex Registry).

Angioplasty of bifurcation lesions represents a continuing challenge. A total of 421 consecutive patients were prospectively followed in a registry on bifurcation stenting with a high-end bare metal stent (Coroflex, BBraun, Berlin, Germany), allowing side branch percutaneous transluminal coronary angioplasty through the stent struts without distraction of the main vessel stent from the vessel wall or other distortions. This approach obviated the 2-wire technique and kissing balloons. Detailed data, including lesion location, stenosis morphology, procedural success, and hospital and follow-up major adverse cardiac events (MACEs; acute myocardial infarction, death, revascularization, hospitalization due to angina), were collected from 6 European centers. Of the patients, 60% had stable angina, 23% had unstable angina pectoris/non-ST-elevation myocardial infarction, and 17% had ST-elevation myocardial infarction. In 17% of patients, the main vessel alone was stented; in 71%, stenting of the main vessel was complemented by side branch percutaneous transluminal coronary angioplasty. Technical success (residual stenosis <50%) in the 2 branches was achieved in 90% (main vessel in 99%). The rate of MACEs at discharge was 2%. After 6 months, 17% of patients had undergone target lesion revascularization or coronary artery bypass grafting. The total 6-month MACE rate was 22%. In conclusion, successful bifurcation stenting with a low MACE rate is possible in most patients using a simplified approach with a dedicated high-end bare metal stent.

Discovering untapped relationship potential with patients in telehealth: a qualitative interview study.

OBJECTIVES: To explore factors that influence relationship building between telehealth professionals and patients with chronic illness over a distance, from a telehealth professional's perspective. DESIGN: 4 focus group interviews were conducted in June 2014. Digital recordings were transcribed verbatim and qualitative content analysis was performed using an iterative process of 3 coding rounds. PARTICIPANTS: 20 telehealth professionals. SETTING: A telehealth service centre in the south of Germany that provided care for 12,000 patients with chronic heart failure across Germany. RESULTS: Non-video telehealth technology creates an atmosphere that fosters sharing of personal information and a non-judgemental attitude. This facilitates the delivery of fair and equal healthcare. A combination of a protocol-driven service structure along with shared team and organisational values provide a basis for establishing long-term healthcare relationships. However, each contact between a telehealth professional and a patient has an uncertain outcome and requires skillful negotiation of the relationship. Although care provision was personalised, there was scope to include the patients as 'experts on their own illness' to a greater extent as advocated by person-centred care. Currently, provision of person-centred care is not sufficiently addressed in telehealth professional training. CONCLUSIONS: Telehealth offers a viable environment for the delivery of person-centred care for patients with long-standing disease. Current telehealth training programmes may be enhanced by teaching person-centred care skills.

The calcium sensitizer levosimendan improves the function of stunned myocardium after percutaneous transluminal coronary angioplasty in acute myocardial ischemia.

OBJECTIVES: We assessed the effects of levosimendan on left ventricular (LV) function in patients with acute myocardial ischemia and after coronary angioplasty. BACKGROUND: The calcium sensitizer levosimendan improves the function of myocardium in experimental stunning. METHODS: Twenty-four patients with an acute coronary syndrome underwent angioplasty followed by double-blinded, randomized treatment with 24 microg/kg of levosimendan (n = 16) or placebo (n = 8). Left ventricular pressures and volumes were recorded by cineventriculography and micromanometer-tipped catheters 10 min after angioplasty before drug administration (baseline) and 20 min after drug administration. Left ventricular function was assessed by the pressure-volume loop, and regional function analysis by the Slager method. RESULTS: The number of hypokinetic segments decreased with levosimendan, from 8.9 +/- 0.9 to 6.5 +/- 1.1 (mean +/- SEM), as compared with an increase from 7.8 +/- 1.0 to 8.5 +/- 1.1 with placebo (p = 0.016). A leftward and/or upward shift of the systolic part of the pressure-volume loop, indicating improved systolic function, was observed in eight of 16 of the levosimendan-treated and one of eight of the placebo patients (p = 0.178). In addition, the single-beat elastance was increased by levosimendan (p = 0.045). The pressure-volume area (p = 0.001), end-systolic pressure (p = 0.002), and volume index (p < 0.001) were decreased by levosimendan, but there was no change in the end-systolic pressure-volume ratio. End-diastolic pressure remained unchanged, whereas the end-diastolic volume index was decreased by levosimendan (p = 0.002). The time constant of isovolumic LV pressure fall decreased with levosimendan (p = 0.001). CONCLUSIONS: Levosimendan improved the function of stunned myocardium without obvious impairment of diastolic function.

Percutaneous extracorporeal life support in patients with circulatory failure: results of the German Lifebridge Registry.

OBJECTIVES: Mortality rates remain high in patients with cardiogenic shock or acute refractory circulatory failure. Extracorporeal life support (ECLS) has been recently introduced into clinical practice for treatment of refractory hypotension in selected patients in combination with rapid restoration of gas exchange. The aim of this study was to evaluate the procedural performance and safety of the automated Lifebridge ECLS system (Zoll Lifebridge GmbH). METHODS: A total of five tertiary cardiovascular centers located in Germany contributed data to this registry (n = 54 patients). Data were collected using a standardized case report form to record clinical characteristics, demographic, procedural, and follow-up data. Patients were included if they were in circulatory crisis (caused by cardiogenic shock or ongoing resuscitation) in an acute setting or in an elective setting during high-risk percutaneous intervention. RESULTS: The Lifebridge device was successfully used in all patients. During elective use, no complications occurred besides 1 minor vascular injury. All elective patients were successfully weaned from the device and alive at the primary endpoint after 30 days. In the emergency setting, 85% of the patients were successfully weaned from the device and 49% of the patients were alive after 30 days. Relevant bleeding resulting in transfusion of red blood cells occurred in 5% of patients. CONCLUSION: In this observational study, we report data from the real-world use of a novel automated ECLS system. Elective use of Lifebridge was feasible and safe without major side effects. In the emergency setting, mortality rates were high; however, stabilization of the selected patients was safe and feasible.

Antiplatelet therapy in the era of percutaneous coronary intervention with drug-eluting balloons.

The high rate of restenosis associated with percutaneous coronary intervention (PCI) procedures can be reduced with the implantation of metallic stents into the stenotic vessels. The knowledge that neointimal formation can result in restenosis after stent implantation led to the development of drug-eluting stents (DES) which require long lasting antiplatelet therapy to avoid thrombotic complications. In the last years, the drug-eluting balloon (DEB) technology has emerged as an alternative option for the treatment of coronary and peripheral arteries. Clinical studies demonstrated the safety and effectiveness of DEB in various clinical scenarios and support the use of paclitaxel-eluting balloons for the treatment of in-stent restenosis, of small coronary arteries and bifurcations lesions. The protocols of DEB studies suggest that the dual antiplatelet therapy with aspirin and clopidogrel of four weeks after DEB is safe and effective.

Occlusion of PFO with a dedicated adjustable device: influence on one year outcome.

AIMS: Though the association of patent foramen ovale with cryptogenic stroke in young patients has been known for 20 years, most interventional closure systems are not specifically designed for PFO closure, but instead are adapted from ASD closure systems. We describe the safety, feasibility and efficacy of transcatheter closure of PFO using a dedicated adjustable device specifically designed to overcome some of the pitfalls of PFO occlusion like erosion, left atrial thrombus formation, embolisation, maladaptation to cardiac structures and excessive foreign material deposition. METHODS AND RESULTS: Seventy-two consecutive patients, aged between 20 and 72 years, underwent PFO occlusion using the Premere® PFO occluder, for the greater part for presumed paradoxical embolism causing cryptogenic stroke or transient ischaemic attack. Forty patients received the 20 mm, while 32 received the 25 mm device. Implantation was successful in all patients. Residual shunt rate, excluding absolutely trivial shunts, was 2.8% at six months on contrast TEE study. Peri- and postprocedural adverse events with some possibility of a causal link to the procedure occurred in six patients. The postprocedural annual recurrence rate (0.99%) was lower than reported in most other series. CONCLUSIONS: PFO occlusion using the dedicated Premere® PFO occluder is effective and safe. The residual shunt rate and post-interventional recurrence rate compares favourably to the literature.

Fenestrated occluders for treatment of ASD in elderly patients with pulmonary hypertension and/or right heart failure.

Atrial septal defect (ASD) occlusion in adult patients with advanced age and left or right heart diastolic or systolic heart failure and in patients with pulmonary arterial hypertension bears a considerable risk of deterioration of heart failure. Therefore, we conducted this feasibility trial in 15 ASD patients with pulmonary hypertension and/or right heart failure using a fenestrated Amplatzer septal occluder (AGA Medical Corporation, Golden Valley, MN), allowing an overflow of blood in both directions in case of univentricular diastolic or systolic heart failure. In all patients, the device could be implanted without complications. All symptomatic patients showed an improvement in the New York Heart Association (NYHA) class, and no right or left heart decompensation occurred. On echocardiography, right ventricular end diastolic dimension (RVEDD) and pulmonary artery pressure (PAP) decreased significantly, whereas left ventricular end diastolic dimension (LVEDD) increased. Our series of 15 patients with fenestrated ASD occlusion shows that high-risk ASD occlusion can safely be accomplished with excellent clinical results and without complications by a fenestrated occluder.

Exclusion of patients with arteriosclerosis reduces long-term recurrence rate of presumed arterial embolism after PFO closure.

BACKGROUND: Percutaneous transcatheter closure of patent interatrial communications after presumed paradoxical embolism is used as an alternative to surgery or long-term anticoagulation for the treatment of patients who are at risk for recurrent thromboembolism. To avoid atherosclerotic events to be judged as recurrent paradoxical embolism, we prospectively excluded all patients with detectable arteriosclerosis from our series and investigated long-term results. METHODS AND RESULTS: We report the outcome of 180 patients who underwent percutaneous transcatheter closure of patent foramen ovale (PFO), PFO like atrial septal defect (ASD), or an ASD because of paradoxical embolism. One hundred four patients had cerebral embolism, 57 had transient ischemic attacks, 16 coronary embolism, and 3 had peripheral embolism. Twenty-three patients experienced multilocal arterial embolism. One hundred twenty-five patients had a PFO, 63 of them with an atrial septal aneurysm (ASA), 24 a PFO-like ASD (7 of them with an ASA), and 31 had an ASD. After 18 months, only 5 patients (2.8%) showed a trivial residual shunt. At a mean follow-up of 40 months (range 4 to 88), resulting in 602 observed patient-years, only 1 patient experienced a presumed paradoxical (coronary) embolism (calculated annual risk to suffer a recurrent thromboembolic event: 0.16%). CONCLUSIONS: Percutaneous transcatheter closure of PFO/ASD is a safe and effective therapeutic option for the secondary prevention of presumed paradoxical embolism. It is associated with a high success rate, low incidence of hospital complications, and very low frequency of recurrent systemic embolic events.

Changes in right ventricular dimensions and performance after passive cardiac containment.

BACKGROUND: Previous studies have shown that the cardiac support device (CSD) improves left ventricular structure and function in patients with heart failure by preventing further cardiac enlargement. The aim of this study was to identify effects on the right ventricle (RV). METHODS: Ten male patients with idiopathic dilated cardiomyopathy underwent electron-beam computed tomographic (CT) examination within 1 month before, and 6 to 9 months after CSD implantation. The RV end-diastolic and end-systolic volumes (EDV, ESV) and diameters (EDD, ESD), stroke volume (SV), ejection fraction (EF), total and forward RV output (RVO, fRVO), and tricuspid regurgitation fraction (TRF) were calculated. RESULTS: The EDV measurements decreased from 182.1 +/- 49.6 to 137.5 +/- 37.0 mL, ESV from 114.8 +/- 47.0 to 68.3 +/- 23.8 mL, EDD from 48.2 +/- 6.6 to 41.6 +/- 7.1 mm, and ESD from 39.6 +/- 6.9 to 32.7 +/- 6.5 mm (p < 0.05 for each). Ejection fraction increased from 38.5 +/- 8.9 to 52.0% +/- 7.7% and fRVO from 4.0 +/- 0.8 to 4.6 +/- 1.1 L/min (each with p < 0.05). TRF decreased from 18.2 +/- 14.1 to 10.4% +/- 13.5%, whereas SV and RVO remained nearly unchanged. Postoperatively, RV volumes, EF, and fRVO were not different from 15 age- and gender-matched normal control patients. CONCLUSIONS: Implantation of a CSD leads to a decrease in RV size and improved RV performance. These data together with the results of previous studies demonstrating improved left ventricular structure and function confirm the biventricular nature of recovery with the CSD.