Elective and primary angioplasty at hospitals without on-site surgery versus with on-site surgery: results from a national registry

INTRODUCTION: Current European clinical guidelines do not restrict interventional cardiology at centers without on-site surgical backup, but disagreement still exists whether hospitals with cardiac catheterization laboratories, but without on-site cardiac surgery, should develop percutaneous coronary intervention (PCI) programs. Technical improvements in equipment and pharmacologic adjunctive therapy have increased the safety margins of diagnostic and therapeutic cardiac catheterization and more than half of the patients treated by PCI in Portugal are treated at hospitals without on-site cardiac surgery. OBJECTIVES: We set out to compare clinical outcomes of elective and primary PCI for ST-segment elevation myocardial infarction at centers without on-site cardiac surgery with those at centers with on-site cardiac surgery. METHODS: Based on the Portuguese Registry of Interventional Cardiology, we retrospectively reviewed a total of 13,235 PCI procedures performed from January 2002 to June 2006 and compared the results for 7,112 patients treated at hospitals without on-site cardiac surgery with 6,123 patients treated at hospitals with on-site cardiac surgery. RESULTS: Demographic data were similar, with a mean age of 64 (55-72) vs. 63 (54-71) years, 75% vs. 76% male and 25.0% vs. 24.2% with diabetes respectively at centers without and with on-site surgical backup. Hospital mortality at centers without and with on-site surgical backup respectively was: chronic angina: 0.3% vs. 0.3% (NS); acute coronary syndromes: 1.5% vs. 1.0% (NS); acute myocardial infarction with ST elevation and without cardiogenic shock: 4.0% vs. 5.0% (NS); cardiogenic shock: 50.9% vs. 53.4% (NS). CONCLUSIONS: Similar clinical outcomes for interventional cardiology were achieved at hospitals without on-site cardiac surgery and those with on-site cardiac surgery. In the era of coronary stents, adjunctive therapy and experienced operators, elective and primary PCI can safely be performed without on-site surgical backup.     

Diagnostic cardiac catheterisation in a hospital without on-site cardiac surgery

OBJECTIVE: To assess the feasibility, safety, and clinical impact of diagnostic cardiac catheterisation in a multipurpose laboratory in a district general hospital without cardiac surgery. METHODS: A prospective audit of the first 2000 consecutive cases between September 1992 and March 1997. Unstable patients were referred to a surgical centre for investigation, in line with subsequently published British Cardiac Society (BCS) guidelines, but all other patients requiring cardiac catheterisation were investigated locally and are included in this report. The function of the laboratory was also compatible with the BCS guidelines regarding staffing, operators, equipment, number of cases, and locally available vascular surgery. RESULTS: Of the 2000 cases, 1988 studies were completed (99%), 1985 (99%) included coronary angiography, and 1798 (90%) were performed as day cases. Left main stem disease was present in 157 (8%), three vessel disease in 683 (34%), two vessel disease in 387 (19%), single vessel disease in 424 (21%), and normal coronary arteries in 494 (25%). Of the latter, 284 (14% of the total) had another cardiac diagnosis for which they were investigated (for example, valvar heart disease). Referral for cardiac intervention following catheterisation was made in 1172 of the 2000 cases (intervention rate 59%; catheter:intervention ratio 1. 7:1). The interventions performed were coronary artery bypass grafting (CABG) in 736 of the 1172 cases (63%), other types of cardiac surgery in 122 (10%), combined CABG and other cardiac surgery in 71 (6%), and percutaneous transluminal coronary angioplasty in 243 (21%). There were two catheter related deaths (0. 1%), both of which occurred within 24 hours of the procedure, and a further nine major cardiovascular complications with residual morbidity (0.45%). These were myocardial infarction in two (0.1%), cerebrovascular events in two (0.1%), and surgical vascular complications in five (0.25%). In addition, there were eight successfully treated, life threatening arrhythmias (0.4%). CONCLUSIONS: Diagnostic cardiac catheterisation can be performed safely and successfully in a local hospital. When BCS guidelines are followed, the mortality is similar to published pooled data from regional centres (0.1% v 0.12%). The high intervention rate indicates a persistent unmet demand in the districts, which will continue to affect surgical and interventional services.     

Long-term cardiac function and outcome in patients receiving primary angioplasty for AMI at a community hospital without on-site surgical back-up

BACKGROUND: Short- and long-term comparative follow-up studies of patients receiving primary angioplasty or thrombolytic therapy for acute myocardial infarction show higher 30-day survival, and sustained benefits in mortality, reinfarction and ejection fraction in patients treated with primary angioplasty. Long-term benefits of primary angioplasty on cardiac function performed in community hospitals without surgical back-up have not been fully assessed. METHODS: Sixty-one patients who underwent primary angioplasty were compared with patients receiving thrombolytic therapy who were matched for age, gender and location of acute myocardial infarction. Clinical information, reviewed through August 2000, was provided by retrospective analysis of healthcare databases and office and hospital charts. Mortality data were confirmed by the social security death index. RESULTS: Of the original 61 primary angioplasty patients, two died during initial hospitalization. Of the 59 surviving patients, fifty-four (92%) had complete follow-up averaging 57 months. Of the original 61 thrombolytic therapy patients, three died during initial hospitalization. Of the 58 surviving patients, fifty-two (90%) had complete follow-up averaging 46 months. At follow-up, averaging 57 months, ejection fraction was significantly higher in the primary angioplasty group, as compared with the thrombolytic therapy group (51.4% versus 45.8%, respectively; p = 0.038). There was no statistical difference between the two groups regarding reinfarction, revascularization at > or = 6 months after the initial presentation or cardiac death. CONCLUSIONS: Primary angioplasty performed in a community hospital without surgical back-up results in improved cardiac function when compared to thrombolytic therapy. These results are similar to those reported from large tertiary centers with on-site surgical back-up, and provide an explanation for the improved long-term outcome that is observed in patients with acute myocardial infarction treated with primary angioplasty.     

Autotransfusion of drained mediastinal blood after cardiac surgery: a reappraisal

In a randomised prospective study the efficacy of autotransfusion was investigated in two groups of 25 patients, a study group in which autologous blood was collected from the mediastinal tubes and retransfused, and a second, control group, in which only stored blood was used. In the study group, a reduction of 50% in the amount of stored blood required was observed. However, in two out of 25 patients the transfusion system could not be used due to clot formation in one of its components. From the total bloodloss per patient about 25% became available for autotransfusion. No significant differences between the two groups were found for hemoglobine, hematocrite, white blood count, platelets and fibrinogen level. Coagulation studies of the drain blood indicate that an active process of mediastinal clotting, followed by fibrinolysis occurs during the losing and collecting. The blood available for retransfusion contained a considerable amount of small-sized debris. It is concluded that autotransfusion of drain blood is not to be recommended for routine use.     

Temporal trends in major angioplasty complications: technical issues and the case for on-site coronary surgery

The need for on-site cardiac surgery has been a component of guidelines for the practice of elective and emergency percutaneous coronary intervention (PCI). However, proportions of cases requiring emergency coronary artery bypass grafting (CABG) post-PCI have fallen. This audit of complications of PCI confirms the very low incidence of need for emergency CABG, despite increasingly complex PCI caseload. Although the availability of stents/antiplatelet pharmacotherapy probably has contributed to improved PCI outcomes, the avoidance of emergency CABG is not contingent on either extensive use of glycoprotein IIb/IIIa inhibitors or strategies of universal stenting.     

Initial experience in the management of myocardial infarction with primary angioplasty: results of the activity in two hospitals of the Turin area without on-site cardiac surgery]

BACKGROUND: Reperfusion therapy of ST-elevation myocardial infarction (STEMI) with primary coronary angioplasty (PTCA) is becoming an accepted therapeutical strategy because of a lower incidence of reinfarction, of hemorrhagic stroke and for a greater reduction of the infarct size in comparison to thrombolytic therapy. In this study we evaluated the feasibility and the effectiveness of such a strategy in two hospitals without on-site heart surgery but with a high volume of admission for acute coronary syndrome and a high caseload of elective interventional procedures. METHODS: Since January 2001 we started a program of primary PTCA for all STEMI patients presenting within 12 hours of symptom onset. An interventional team (physician, nurse and technician) were on call in a 24/7/365 fashion. Aspirin, heparin and abciximab were administered in the emergency room to all patients. Immediately after the procedure patients were given clopidogrel. RESULTS: Up to December 2003, 464 patients (mean age 63 +/- 12 years, 19.8% female) underwent primary PTCA. The symptom-emergency room interval was 3 +/- 3.9 hours, while the door-to-balloon time was 52.5 +/- 39.4 min. A TIMI 0-1 flow in the infarct-related artery was present in 55.8% of patients. Seventy patients (15.1%) presented with shock. In 430 patients (92.7%) a TIMI 3 flow was restored followed by a reduction in ST-segment elevation > 50% in 356 patients (76.7%). Total in-hospital mortality was 4.9% (23 out of 464 patients). The mortality of patients with shock was 31.4% (22 out of 70 patients). Two patients (0.4%) underwent emergency bypass. Four patients (0.8%) were electively referred to surgery prior to discharge in order to complete revascularization, which could not be obtained with further PTCA. The rate of major hemorrhagic complications was 0.8%. CONCLUSIONS: Primary PTCA for STEMI is a reperfusion strategy feasible and effective even in hospitals without on-site heart surgery, provided that a high volume of routine and emergency interventional procedures is maintained and when such a strategy is timely performed according to international guidelines.     

Chest physiotherapy: time for reappraisal

Chest physiotherapy should now be updated with attention to three important features: first, its use should be limited to those patients with actual or potential sputum production and its central aim should be to increase expectoration. Second, it should incorporate the forced expiration technique with postural drainage and omit traditional elements such as percussion and vibration. Third, the additional use of inhaled adrenergic agents and possibly oral high frequency oscillation may increase sputum clearance further.     

Primary angioplasty in acute myocardial infarction at hospitals with no surgery on-site (the PAMI-No SOS study) versus transfer to surgical centers for primary angioplasty

OBJECTIVES: To investigate primary angioplasty (PA) for high-risk acute myocardial infarction (AMI) at hospitals with no cardiac surgery on-site (No SOS), we hypothesized that a nonrandomized registry of such patients treated with PA would show clinical outcomes similar to those of a group randomized to transfer for PA, and that reperfusion would occur faster. BACKGROUND: Primary angioplasty provides outcomes superior to fibrinolytic therapy in AMI, but its use in community hospitals with No SOS has been limited. METHODS: Fibrinolytic-eligible patients with high-risk AMI prospectively consented if they had one or more high-risk characteristic. Nineteen hospitals with No SOS prospectively enrolled 500 patients for PA on-site. Seventy-one similar Air Primary Angioplasty in Myocardial Infarction trial patients were randomized to transfer for PA. RESULTS: Primary angioplasty was performed in 88% of patients. Patients transferred for PA had a longer mean time to treatment (187 vs. 120 min; p < 0.0001). Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 was achieved in 96% for on-site PA, 86% in the transfer group (p = 0.004). The combined primary end point of 30-day mortality, re-infarction, and disabling stroke occurred in 27 (5%) on-site PA patients and 6 (8.5%) transfer patients (p = 0.27). Unadjusted one-year mortality was improved in on-site PA patients compared with those transferred (6% vs. 13%, p = 0.043), but after adjustment for differences in baseline variables, this difference was not significant. CONCLUSIONS: On-site PA and transfer groups had similar 30-day outcomes and more rapid reperfusion for on-site PA. Primary angioplasty in high-risk AMI patients at hospitals with No SOS is safe, effective, and faster than PA after transfer to a surgical facility.     

Percutaneous coronary intervention with vs without on-site cardiac surgery backup: a systematic review and meta-analysis

Although the popularity of performing percutaneous coronary intervention (PCI) in centres without on-site cardiac surgery backup is increasing, the safety of this practice is unknown. Our goal was to perform a systematic review and meta-analysis of PCI with and without on-site cardiac surgery backup. We identified studies using computerized literature searches through July 2009. Main outcomes of interest included in-hospital mortality and early coronary artery bypass grafting (CABG). Analyses were stratified by procedure indication (primary PCI and nonprimary PCI). Pooled estimates were obtained using random-effects models. We identified 9 primary PCI studies (106,089 patients) and 7 nonprimary studies (910,422 patients) comparing centres with and without on-site cardiac surgery. For primary PCI, centres without on-site surgery had no significantly increased risk of in-hospital mortality (odds ratio [OR] 0.93; 95% confidence interval [CI], 0.83-1.05) or early CABG (OR 0.87; 95% CI, 0.68-1.11) compared with centres with on-site surgery. For nonprimary PCI, no increased risk of in-hospital mortality (OR 1.03; 95% CI, 0.64-1.66) and early CABG (OR 1.38; 95% CI, 0.65-2.95) was observed in centres without backup. However, significant heterogeneity existed in estimates of nonprimary PCI studies, suggesting substantial variation in outcomes of nonprimary PCI across centres without on-site cardiac surgery. We demonstrated that rates of in-hospital mortality and early CABG were similar at PCI centres with and without on-site cardiac surgery backup. However, variations in outcomes suggest that assurance of optimal outcomes at each PCI centre without on-site surgery is needed.     

'Test and treat' policy in dyspepsia: time for a reappraisal

The 'test and treat' policy is the recommended way to eradicate Helicobacter pylori in young patients with uninvestigated dyspepsia if the prevalence of H. pylori is high. India is considered to have a high prevalence of H. pylori. This observational study was conducted in order to discover the prevalence of H. pylori disease in uninvestigated dyspeptic patients, based on stool antigen test and immunoglobulin M (IgM) antibodies in the sera in order to ascertain the role of the 'test and treat' policy in this geographical area. Fifty patients (age <55 years) with uninvestigated dyspepsia presenting to surgery out-patient department of a tertiary teaching hospital in northern India were included in the study. Fifty healthy controls were also included. Dyspeptic patients with alarm symptoms were excluded from the study. Patients and controls were tested for IgM antibodies in their sera and H. pylori antigen in their stools. The positivity of the IgM antibody and H. pylori antigen in stools of the cases was 16% and 8%, respectively, while only 4% IgM positivity was found in the controls' samples. This study highlights the low prevalence of H. pylori in dyspeptic Indian patients. This indicates that initial proton pump therapy may be a better option than the 'test and treat' policy for young patients with uninvestigated dyspepsia.     

Does a waiting time for elective coronary angioplasty affect the primary success rate?

OBJECTIVE: To evaluate the effect of the waiting time for elective percutaneous transluminal coronary angioplasty (PTCA) on the primary success rate. SETTING: University hospital in The Netherlands. PATIENTS: A cohort of 817 consecutive patients awaiting elective PTCA. Scheduled PTCA was performed in all 817 patients, involving 1237 coronary lesions. MAIN OUTCOME MEASURES: The relation between procedural success and the duration of the waiting time was evaluated. Major cardiac events, that is, death and myocardial infarction while awaiting PTCA, were documented. Alterations in lesion characteristics during the waiting time were assessed in unsuccessful procedures. RESULTS: Elective PTCA was performed within one to six weeks after acceptance in 388 patients (587 lesions; 47.5%), between six and 12 weeks in 203 patients (308 lesions; 25%), and after more than 12 weeks in 226 patients (342 lesions; 27.5%). The procedural success rates in the defined time intervals were 97%, 99%, and 97% in ACC/AHA type A lesions, 93%, 87% and 90% in type B lesions, and 63%, 55% and 38% in type C lesions respectively; 96% of type C lesions were total coronary occlusions. There was a significant decrease in primary success rate in type C lesions after a waiting time beyond 12 weeks. A reasonable explanation for an unsuccessful angioplasty related to alterations in lesion characteristics during the waiting time was documented in only four of 115 procedures. CONCLUSIONS: The primary success in type A and B lesions is unaffected by the duration of a waiting period for elective PTCA. A waiting time of more than 12 weeks is associated with a lower success rate in patients with total coronary occlusions.     

The medical use of oxygen: a time for critical reappraisal

Oxygen treatment has been a cornerstone of acute medical care for numerous pathological states. Initially, this was supported by the assumed need to avoid hypoxaemia and tissue hypoxia. Most acute treatment algorithms, therefore, recommended the liberal use of a high fraction of inspired oxygen, often without first confirming the presence of a hypoxic insult. However, recent physiological research has underlined the vasoconstrictor effects of hyperoxia on normal vasculature and, consequently, the risk of significant blood flow reduction to the at‐risk tissue. Positive effects may be claimed simply by relief of an assumed local tissue hypoxia, such as in acute cardiovascular disease, brain ischaemia due to, for example, stroke or shock or carbon monoxide intoxication. However, in most situations, a generalized hypoxia is not the problem and a risk of negative hyperoxaemia‐induced local vasoconstriction effects may instead be the reality. In preclinical studies, many important positive anti‐inflammatory effects of both normobaric and hyperbaric oxygen have been repeatedly shown, often as surrogate end‐points such as increases in gluthatione levels, reduced lipid peroxidation and neutrophil activation thus modifying ischaemia–reperfusion injury and also causing anti‐apoptotic effects. However, in parallel, toxic effects of oxygen are also well known, including induced mucosal inflammation, pneumonitis and retrolental fibroplasia. Examining the available ‘strong’ clinical evidence, such as usually claimed for randomized controlled trials, few positive studies stand up to scrutiny and a number of trials have shown no effect or even been terminated early due to worse outcomes in the oxygen treatment arm. Recently, this has led to less aggressive approaches, even to not providing any supplemental oxygen, in several acute care settings, such as resuscitation of asphyxiated newborns, during acute myocardial infarction or after stroke or cardiac arrest. The safety of more advanced attempts to deliver increased oxygen levels to hypoxic or ischaemic tissues, such as with hyperbaric oxygen therapy, is therefore also being questioned. Here, we provide an overview of the present knowledge of the physiological effects of oxygen in relation to its therapeutic potential for different medical conditions, as well as considering the potential for harm. We conclude that the medical use of oxygen needs to be further examined in search of solid evidence of benefit in many of the current clinical settings in which it is routinely used.