Consensus guidelines for interventional cardiology services delivery during covid-19 pandemic in Australia and new Zealand.

The global coronavirus disease (COVID-19) pandemic poses an unprecedented stress on healthcare systems internationally. These Health system-wide demands call for efficient utilisation of resources at this time in a fair, consistent, ethical and efficient manner would improve our ability to treat patients. Excellent co-operation between hospital units (especially intensive care unit [ICU], emergency department [ED] and cardiology) is critical in ensuring optimal patient outcomes. The purpose of this document is to provide practical guidelines for the effective use of interventional cardiology services in Australia and New Zealand. The document will be updated regularly as new evidence and knowledge is gained with time. Goals Considerations.

An electronically instrumented internal fixator for the assessment of bone healing.

OBJECTIVES: The monitoring of fracture healing is a complex process. Typically, successive radiographs are performed and an emerging calcification of the fracture area is evaluated. The aim of this study was to investigate whether different bone healing patterns can be distinguished using a telemetric instrumented femoral internal plate fixator. MATERIALS AND METHODS: An electronic telemetric system was developed to assess bone healing mechanically. The system consists of a telemetry module which is applied to an internal locking plate fixator, an external reader device, a sensor for measuring externally applied load and a laptop computer with processing software. By correlation between externally applied load and load measured in the implant, the elasticity of the osteosynthesis is calculated. The elasticity decreases with ongoing consolidation of a fracture or nonunion and is an appropriate parameter for the course of bone healing. At our centre, clinical application has been performed in 56 patients suffering nonunion or fracture of the femur. RESULTS: A total of 39 cases of clinical application were reviewed for this study. In total, four different types of healing curves were observed: fast healing; slow healing; plateau followed by healing; and non-healing. CONCLUSION: The electronically instrumented internal fixator proved to be valuable for the assessment of bone healing in difficult healing situations. Cost-effective manufacturing is possible because the used electronic components are derived from large-scale production. The incorporation of microelectronics into orthopaedic implants will be an important innovation in future clinical care.Cite this article: B. Kienast, B. Kowald, K. Seide, M. Aljudaibi, M. Faschingbauer, C. Juergens, J. Gille. An electronically instrumented internal fixator for the assessment of bone healing. Bone Joint Res 2016;5:191-197. DOI: 10.1302/2046-3758.55.2000611.

Patients' Adherence in the Maintenance Therapy of Children and Adolescents with Acute Lymphoblastic Leukemia.

BACKGROUND: Acute lymphoblastic leukemia (ALL) is the most common form of paediatric cancer. Maintenance therapy as last treatment phase includes oral chemotherapy with methotrexate (MTX) and mercaptopurine (6-MP), self- or parent-administered at home, given for about 1 ½ years, and qualified as decisive for an optimum therapy outcome. The aim of our study was to analyze factors influencing the adherence of patients with ALL undergoing maintenance therapy and their families. METHODS: A multi-method study was undertaken between 11/2011 and 10/2014 with patients surveyed by the Hannover Medical School outpatient clinic, including a questionnaire survey and qualitative interviews with parents as well as blood samples of the patients. RESULTS: 33 questionnaires, 27 interviews and blood samples of 26 patients could be analyzed. Only one third of the blood samples showed concentrations of the 6-MP active metabolite within the therapeutic reference range. Parents named the clinical doctor as their main advisor on medication intake. 36% (12/33) of the participants stated that medication intake has not always occurred the way medication was prescribed. Drug formulation and drug intake information could be identified as determinants of adherence. Parents' problems to obtain information are partly caused by different study results concerning the correct timing of the drug intake and drug interactions with milk products. CONCLUSION: Parents' information on drug therapy should be more consistent and the pharmaceutical formulations have to be adapted to patients' needs to improve adherence and thereby the chance of long-term remission.

Long-term outcomes in patients with restrictive filling following ST-segment elevation myocardial infarction.

This study evaluated the effect of restrictive filling pattern (RFP) on 5-year outcomes in patients following ST-segment elevation myocardial infarction (STEMI). A hundred STEMI patients treated either by rescue or primary percutaneous coronary intervention with an echocardiogram performed within 6 weeks of STEMI comprised the study group. Creatinine kinase (CK) and left ventricular ejection fraction were independent determinants of RFP, and RFP was an independent predictor of cardiac and all-cause mortality at median follow up of 5 years.

A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged ≥65 years.

This randomized, double-blind study evaluated concomitant administration of 13-valent pneumococcal conjugate vaccine (PCV13) and trivalent inactivated influenza vaccine (TIV) in adults aged ≥65 years who were naïve to 23-valent pneumococcal polysaccharide vaccine. Patients (N=1160) were randomized 1:1 to receive PCV13+TIV followed by placebo, or Placebo+TIV followed by PCV13 at 0 and 1 months, with blood draws at 0, 1, and 2 months. Slightly lower pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G geometric mean concentrations were observed with PCV13+TIV relative to PCV13. Concomitant PCV13+TIV demonstrates acceptable immunogenicity and safety compared with either agent given alone.

Early Weight Bearing of Calcaneal Fractures Treated by Intraoperative 3D-Fluoroscopy and Locked-Screw Plate Fixation.

Operative therapy of intraarticular fractures of the calcaneus is an established surgical standard. The aim is an accurate reduction of the fracture with reconstruction of Boehler's angle, length, axis and subtalar joint surface. Intraoperative 3D-fluoroscopy with the Siremobil Iso-C 3D(R) mobile C-arm system is a valuable assistant for accurate reconstruction of these anatomical structures. Remaining incongruities can be recognized and corrected intraoperatively. The achieved reduction can be fixed by the advantages of an internal fixator (locked-screw plate interface). In the period of October 2002 until April 2007 we operated 136 patients with intraarticular fractures of the calcaneus by means of anatomical reduction, and internal plate fixator under intraoperative control of 3D-fluoroscopy. All patients were supplied with an orthesis after the operation which allowed weight bearing of 10 kg for 12 weeks for the patients operated between October 2002 and October 2004 (Group A). Transient local osteoporosis was observed in all X-Rays at follow-up after an average of 8,6 months. Therefore we changed our postoperative treatment plan for the patients operated between November 2004 and April 2007 (Group B). Weight bearing started with 20 KG after 6 weeks, was increased to 40 KG after 8 weeks and full weight bearing was allowed after 10 weeks for these patients. In no case a secondary dislocation of the fracture was seen. No bone graft was used. At follow up the average American Foot and Ankle Society Score (AOFAS) were 81 for Group_A, compared to 84 for Group B, treated with earlier weight bearing. Autologous bone graft was not necessary even if weight bearing was started after a period of six weeks postoperatively. The combination of 3D-fluoroscopy with locked internal fixation showed promising results. If the rate of patients developing subtalar arthrosis will decrease by this management will have to be shown in long term follow up.

The pharmaco-invasive approach to STEMI: when should fibrinolytic-treated patients go to the "cath lab"?

Although primary percutaneous coronary intervention (PCI) in clinical trials has lower rates of reinfarction, stroke and mortality than fibrinolytic therapy, because of system delays in routine practice, field triage and prehospital administration of fibrinolytic therapy may lead to similar clinical outcomes, especially in those patients who present in the first 2 h after symptom onset. Necessary for these outcomes is the liberal use of both rescue PCI and in-hospital revascularisation. Non-invasive prediction of failed reperfusion may be enhanced by the use of ST recovery, patient characteristics and troponin T levels, measured by point-of-care assays. This review focuses on the timing of, and indications for, an invasive strategy after fibrinolytic therapy, including that for failed pharmacological reperfusion.

Nephrotoxic effects of iodixanol and iopromide in patients with abnormal renal function receiving N-acetylcysteine and hydration before coronary angiography and intervention: a randomized trial.

BACKGROUND: The use of contrast agents during coronary intervention can result in nephropathy, particularly in patients with renal dysfunction. We aimed to determine whether the use of iso-osmolar iodixanol is less nephrotoxic than that of low-osmolar iopromide when patients are adequately prehydrated and have received N-acetylcysteine. METHODS: We conducted a randomized, double-blind, multicentre study of patients with impaired renal function undergoing a coronary interventional procedure. Primary end-point was the incidence of contrast-induced nephropathy (CIN) on day 2, defined as an increase in serum creatinine concentration of > or =44 micromol/L (0.5 mg/dL) or by a relative increase of > or =25% from baseline. Secondary end-points included peak increase in serum creatinine between baseline and day 7. RESULTS: Of 191 patients recruited, 15% (95% CI: 8-22) of the patients receiving iopromide and 12% (95% CI: 5-19) of the patients receiving iodixanol developed CIN (95% CI of the difference: 13 to -7, P = 0.56). When including peak serum creatinine on day 7, CIN developed in 23% of patients receiving iopromide and in 27% of patients receiving iodixanol (95% CI of the difference: 8 to -16, P = 0.48). The peak increase in serum creatinine concentration at day 7 was similar in both groups (patients receiving iopromide, 18.4 +/- 24.4 micromol/L, vs patients receiving iodixanol, 21.9 +/- 24.2 micromol/L; P = 0.33). CONCLUSION: There remains a high incidence of CIN despite prehydration and routine use of N-acetylcysteine in patients with pre-existing renal dysfunction undergoing coronary interventional procedures. Although our study is underpowered, iodixanol was not associated with a statistically significant lower incidence of CIN when compared with iopromide.

The pharmaco-invasive approach to STEMI: when should fibrinolytic-treated patients go to the "cath lab"?

Although primary percutaneous coronary intervention (PCI) in clinical trials has lower rates of reinfarction, stroke and mortality than fibrinolytic therapy, because of system delays in routine practice, field triage and prehospital administration of fibrinolytic therapy may lead to similar clinical outcomes, especially in those patients who present in the first 2 h after symptom onset. Necessary for these outcomes is the liberal use of both rescue PCI and in-hospital revascularisation. Non-invasive prediction of failed reperfusion may be enhanced by the use of ST recovery, patient characteristics and troponin T levels, measured by point-of-care assays. This review focuses on the timing of, and indications for, an invasive strategy after fibrinolytic therapy, including that for failed pharmacological reperfusion.

How compliant are we with guidelines for coronary angiography in clinical practice?

BACKGROUND: The American College of Cardiology and American Heart Association have published guidelines for coronary angiography. We evaluated the compliance rate with these guidelines in clinical practice, its correlation to results of angiography and aimed to identify problem areas of non-compliance. METHODS: We prospectively evaluated 802 consecutive referrals for coronary angiography over 5 months in 2002 in a tertiary referral hospital. These referrals were assessed by two independent reviewers blinded to the results of angiography. RESULTS: Patient age was 62 +/- 11 years (522 men, 433 inpatients, 369 day-only patients). Referrals were outside published guidelines in 34.3 and 36.2% as evaluated by the two reviewers (concordance rate 88.2%, kappa = 0.74, p < 0.001). Intraobserver agreement was 97.5%. The rate of angiography showing either normal arteries or only minor diseases (<50%) was higher for referrals outside guidelines (68.4 vs 22.6%, P < 0.001). Compliance rate was high with indications of non-ST-elevation myocardial infarction (99.2%) and ST-elevation myocardial infarction (95.8%), valvular disease (80%) and arrhythmia (80%). Compliance rate was lower with assessment of dyspnoea or heart failure (74.3%) and before non-cardiac surgery (72.7%) and was particularly low with assessment of chest pain (53.2%). Younger age (odds ratio (OR) 1.04, P < 0.001), female sex (OR 2.67, P < 0.001), day-only procedure (OR 2.27, P < 0.001) and non-invasive cardiologist referrer (OR 1.41, P = 0.046) were independent predictors of non-compliance. CONCLUSION: Referrals for coronary angiography were outside guidelines in a significant proportion of patients. Rate of negative angiography was higher when the referrals were outside guidelines. Problematic areas of non-compliance could be identified. Measures specifically targeting these areas may be more effective in improving the overall guideline compliance in clinical practice.

Use of a quantitative point-of-care test for the detection of serum cardiac troponin T in patients with suspected acute coronary syndromes.

We compared a third generation quantitative cardiac troponin T (cTnT) point-of-care testing (POCT) from Roche Diagnostics with the laboratory assay (Roche Elecsys 2010 immunoassay analyser). Heparin-treated blood and serum were collected simultaneously in 133 unselected patients (mean age 62 +/- 14 years, 38% females) presenting to our hospital with possible cardiac chest pain. Results of the POCT were measured against the laboratory-based assay considered as the gold standard. There were 18 POCT positive versus 24 laboratory assay positive (> or = 0.03 ng/mL) patients. POCT was falsely negative in six patients, with values between 0.03 and 0.1 ng/mL. The POCT had a sensitivity of 75%, specificity of 100%, positive predictive value of 100%, negative predictive value of 95% and a total accuracy of 95%; kappa = 0.831 (P < 0.001). There was good correlation between the values of POCT and the laboratory assay: Y = 1.195X + 0.002, r2 = 0.94 (P < 0.0001). Whereas cTnT levels > 0.1 mg/mL were reliably detected with this current generation of POCT, cTnT levels between 0.03 and 0.10 ng/mL were not. Future generations of devices will need to improve sensitivity to reliably risk stratify patients with suspected acute coronary syndromes.

[Sixty-four cases of percutaneous coronary angioplasty on saphenous vein bypass grafts].

OBJECTIVE: To evaluate the early clinical result of percutaneous transluminal coronary intervention (PCI) and stenting on saphenous vein grafts. METHODS: Percutaneous intervention was performed in 91 saphenous vein grafts in 64 patients. The data of clinical results during operation and hospitalization and that of other interventional assisting device were recorded in database and were analyzed. RESULTS: The success rate of operation was 95.3%, non-Q wave myocardial infarction occurred in 1 patient (1.6%) and temporary no-reflow phenomenon occurred in 4 patients (6.3%) during operation. Reduced antegrade flow and ventricular fibrillation happened in 1 patient after stenting and normal antegrade flow obtained after cardiac compression and tracheal intubation and insertion of IABP. The distal protection devices were used in 7 patients (10.9%), X-sizer extraction system in 4 patients. Platelet glycoprotein IIb/IIIa receptor blockers were administered in 25 patients (35.9%). Non-Q wave myocardial infarction occurred in two cases, the incidence of major adverse clinical event was 3.1% during the period of hospitalization. CONCLUSIONS: The instant success rate of PTCA and stenting of saphenous vein bypass grafts is high and recent clinical result is promising, but the middle and long term results remain to be further followed. The use of distal embolic protection device and GPIIb/IIIa receptor blockers may improve its prognosis.

Accuracy of implanted port placement with the use of the electromagnetic CathTrack catheter locator system.

PURPOSE: To test whether an electromagnetic guidance system such as CathTrack would allow long-term central venous access devices to be reliably placed at a decreased cost and without radiation exposure to patients and staff. The following study was undertaken to verify accuracy of the CathTrack system for catheter placement and to develop guidelines for its use. METHODS: Twenty-nine consecutive patients were prospectively enrolled in the study and taken to the operating room for implantation of a permanent central venous access port. By protocol, the CathTrack system was used to guide initial catheter positioning using the center of the third intercostal space along the right sternal border as the desired external target. Fluoroscopy was then used to visualize tip position and relocate the catheter tip to the exact position desired by the surgeon. RESULTS: Catheter placement using the CathTrack system was successfully accomplished in 27 out of 29 patients. In two instances CathTrack was abandoned and fluoroscopy utilized because of difficulty in threading the initial guidewire into the superior vena cava. CONCLUSION: The CathTrack electromagnetic locator system can be used to reliably position catheters for the establishment of long-term central venous access. Decreased cost and elimination of radiation exposure are distinct advantages of this system over fluoroscopy.

A hexapod robot external fixator for computer assisted fracture reduction and deformity correction.

Using hexapod robot kinematics, an external fixator adjustable in all six spatial degrees of freedom was developed. As usual with a robot system, bone movements can be accomplished with high precision. Contrary to conventional external fixators any three-dimensional movement is realisable without giving up stability or the necessity to change parts of the construction during the treatment. At first a manually controlled fixator with appropriate software was developed. Then electromotor elements were added, resulting in a "fracture reduction robot" and a fixator featuring load measurement capabilities was built. Finally the concept was extended into an "intelligent fixator" which will accomplish automatically controlled fracture and deformity treatment in the future.

A novel approach for crossing a virtually occluded vessel using ultra-low-profile balloon backup.

We discuss a case in which a novel ultra-low-profile angioplasty balloon was used to provide wire backup by advancing the uninflated balloon nose into the entry point of a virtually occluded lesion. This enabled crossing of the lesion, and demonstrates how an improved balloon design can directly lead to improved clinical outcomes.

Right ventricular perforation with cardiac tamponade associated with use of a temporary pacing wire and abciximab during complex coronary angioplasty.

We describe our recent experience of right ventricular perforation leading to cardiac tamponade associated with a complex coronary angioplasty in which abciximab and a temporary pacing wire were used. This is to highlight the possibility that the combined use of temporary pacing wires and the IIb/IIIa receptor antagonists may be associated with an increased risk of this serious complication. Cathet. Cardiovasc. Intervent. 48:388-389, 1999.