Showing posts with label cardioverter-defibrillators. Show all posts
Showing posts with label cardioverter-defibrillators. Show all posts

Tuesday, 18 January 2011

JOURNAL SNIPPETS JAN 11

JAMA 12 Jan 2011 Vol 305
167 Single combat between mounted Mongolian warlords, and arguments between cardiac surgeons - these are spectator sports which it is best not to stand too close to. It is an article of faith that in coronary bypass operations, radial artery grafts always outperform saphenous vein grafts. Here is a study with 36 authors to show that there is no difference in patency at one year. Gentlemen, get down from your horses, please: some of these guys are Texans.
http://jama.ama-assn.org/content/305/2/167.abstract

175 We need to know more about the effect of the drugs we use for heart failure in the general mix of patients we treat in the community. The randomised controlled trials tell us a lot about specific drugs, usually when added to standard treatments in selected populations, but this may be an area where observational studies done on typical populations are just as valuable. That said, certainty is never going to be on offer, given the difficulties of defining the diagnosis and the impossibility of eliminating confounders: there is no such thing as heart failure without co-morbidity. So two cheers for this Swedish population database study which tried, but did not altogether succeed, in matching two groups of heart failure patients who took losartan or candesartan, and tracking their mortality over five years. Those taking candesartan showed better survival. It would be nice to do a similar comparison using the UK GP Research Database, but they have just made that harder by withdrawing free access.
http://jama.ama-assn.org/content/305/2/175.full

JAMA 5 Jan 2011 Vol 305
43 Implantable cardioverter-defibrillators are a good intervention for those who have bad systolic heart failure with a risk of ventricular arrhythmia, and would rather die slowly than suddenly. The "utility" of the device is that it can have a statistically significant effect on mortality in younger, properly selected patients; the "dysutility" includes everything that can go wrong with the machines and the possibility that dying from pump failure may be accompanied by multiple painful electric shocks. As you'll gather, I'm not a great fan of these devices, but most cardiologists are. In the USA, their use by Medicare and Medicaid was approved in 2005, since when a registry has been kept, and this study examines it to find out how many ICD implantations were not evidence-based. Using agreed criteria, the answer is about 22.5%, meaning that between a fifth and a quarter of all ICDs cannot be expected to do any good to the patient, while the potential for harm is considerable. I wonder what kind of informed, shared decision-making goes on before these things are inserted into people?
http://jama.ama-assn.org/content/305/1/43.abstract

NEJM 6 Jan 2011 Vol 364
11 Here's a classic pharma-funded trial of eplerenone in systolic heart failure with mild symptoms: EMPHASIS-HF. Pfizer paid for patients to be recruited in 278 centres in 29 countries, with fewer than 10 patients per centre; their mean age was 69, with none reaching 76, the mean age of heart failure patients in the community; and 78% of them were male. The trial was stopped prematurely when the eplerenone group showed a large reduction in the composite end-point of death and readmission. So we know that the drug works for this group of patients, though the effect size and long term effects cannot be known accurately due to early termination. We have no idea what the drug does for symptoms, since these weren't considered. We don't know what its effects will be on older patients with comorbidities, or on patients with heart failure and a normal ejection fraction. It will probably cause much more serious hyperkalaemia in the community than in the trial, as was the case with spironolactone following the RALES study. Sales of eplerenone will soar in its last few years on patent, and the heart failure community will be happy that its academic centres and conferences will have been paid for until the next bonanza comes along. Meanwhile, clinicians will struggle to know what best to do for their patients, especially as a quarter of the patients in this trial had QRS prolongation and should have had biventricular pacing.
http://www.nejm.org/doi/full/10.1056/NEJMoa1009492

Wednesday, 10 November 2010

JOURNAL SNIPPETS November

JAMA 3 Nov 2010 Vol 304
1950 Heart failure research in the mid-1990s was to discover that a lot of elderly patients with obvious clinical heart failure had high levels of B-type natriuretic peptide but a normal systolic ejection fraction. British cardiologists said there is no such thing as "diastolic heart failure" and treasonable talk of this kind would stop people having echocardiograms and taking the maximal doses of ACE inhibitors and beta-blockers that real heart failure requires. A provisional understanding of this kind of heart failure is not based solely on events in diastole but also to stiffening of the main capacitance arteries. It is extremely common in people over 75 and we don't know how to treat it, partly because cardiologists and drug companies remain uninterested; as this short commentary on "age disparities in heart failure research" points out.
http://jama.ama-assn.org/cgi/content/extract/304/17/1950

Ann Intern Med 2 Nov 2010 Vol 153
553 With stockings, the longer the better. This is not merely a fetishist preference, but carries the imprimatur of the Medical Research Council of the United Kingdom, the Chief Scientist Office of the Scottish Government, and Chest Heart and Stroke Scotland, the funders of the CLOTS trail collaboration. This clottish acronym is derived from Clots in Legs Or sTockings after Stroke. The subjects were 3114 patients in 112 hospitals (no, they don't have that many in Scotland - the trial covered 9 countries) immobilized by stroke. They were randomised to have below-knee or thigh length compression hose. The latter had fewer clots in their proximal deep veins.
http://www.annals.org/content/153/9/553.abstract

587 Eight Italian meta-analysts go to work on the trials of prophylactic implantable cardioverter-defibrillators. These expensive devices often malfunction with shocking consequences but they probably save a few younger patients from sudden death. But in people of sixty and over - called "elderly" by these authors, perhaps through a limited knowledge of the English language - there is no clear evidence of benefit. Purchasers of care, take note, and do not be duped by interventional cardiologists: biventricular pacing saves lives but putting in an ICD at the same time is usually wrong.
http://www.annals.org/content/153/9/592.abstract

Monday, 5 July 2010

JOURNAL SNIPS

This week includes abstracts from the NEJM and Archives of Internal Medicine

NEJM 1 Jul 2010 Vol 363
36
Implantable cardioverter-defibrillators often go wrong due to lead failure, and they can lead to shockingly bad ends in heart failure. This trial assesses a new type of ICD which does not rely on venous access but is entirely subcutaneous, delivering shocks to the thorax close to the heart. Its success depended a lot on accurate positioning, and over the ten months of the trial it worked well and appropriately, though it's too soon of course to say anything about long-term reliability, let alone long-term mortality benefit.
http://content.nejm.org/cgi/content/abstract/363/1/36

Arch Intern Med 28 Jun 2010 Vol 170
1024
On to statins .... Among patients with known cardiovascular disease, statins are drugs which are very hard to find any benefit once heart failure has set in. But prescribing statins to high-risk patients for primary prevention may be futile, according to this literature-based meta-analysis. It is a very hard paper to follow, however, with a fairly heterogeneous mix of studies which are not adequately characterised or analysed in these six pages: to do that would require twice the length, or ideally an entire database, which could then be analysed on an individual patient basis...
http://archinte.ama-assn.org/cgi/content/abstract/170/12/1024
1032 The JUPITER trial of rosuvastatin was stopped early and has been a source of controversy ever since. The acronym stands for Justification for the Use of Statins in Primary Prevention, but when JUPITER's data are fed into a meta-analysis like the one we've just seen, there is no such Justification. In fact the data of this trial are internally contradictory in a way that strongly suggests manipulation, according to this critical reappraisal, which suggests that Jove's ire should be directed at the role of commercial sponsors. I can hear the distant peal of thunder across the Atlantic: Jupiter tonans.
http://archinte.ama-assn.org/cgi/content/abstract/170/12/1032
1037 The well-conceived new Archives series called LESS IS MORE here lives up to its radical credentials: we are giving diabetic patients too many drugs for cardiovascular protection. Again, this flies in the face of what we have been taught over the last few years. It also seems to fly in the face of the calculation done by these authors that treating to targets for LDL-cholesterol and blood pressure results in gains of 1.5 and I.35 quality-adjusted years respectively. But they demonstrate that these overall gains are largely accounted for by the treatment of a small number of very high-risk individuals, and that the more drugs you put in, the more you are likely to achieve minimal benefit or actual harm. A key paper in the continuing debate about targets in type 2 diabetes.
http://archinte.ama-assn.org/cgi/content/abstract/170/12

Thursday, 8 October 2009

JOURNAL SNIPS

NEJM 1 Oct 2009 Vol 361
1329 Cardiac resynchronisation therapy (dual chamber pacing) is a good intervention for about two thirds of patients with heart failure due to systolic dysfunction. We’ve known that for a while, and it’s worth repeating because it’s an under-used treatment in the UK and one that’s worth fighting for in a time of financial restraint. Implantable cardioverter-defibrillators, on the other hand, are of dubious value to most heart failure patients, especially women, and at the end stage prevent sudden painless death at the shocking (literally) cost of repeated firings and drowning from pulmonary oedema. So I have grave misgivings about the design of this trial to prevent overt heart failure in patients with minimal breathlessness but severely impaired systolic function, either due to ischaemia or non-ischaemic cardiomyopathy. They were relatively young (mean 64) and nearly asymptomatic despite having a mean LVEF of 24%. They were all fitted with ICDs; half of them also with dual chamber pacemakers. The trial was stopped early as the paced group had 41% fewer episodes of overt heart failure. These are not the kind of heart failure patients you see much of in primary care, so it doesn’t get us all that far. However, it’s consistent with my headline message: think biventricular pacing for all your appropriate real-life HF patients, think ICD for very few. http://content.nejm.org/cgi/content/abstract/361/14/1329

1368 One patient I remember was a sculptor who ended an anecdote with the words “I nearly killed him with my bare hands!” The great surgeon moved on, laughing grimly, “I’ve killed plenty of people with my hands”. Hospital mortality associated with inpatient surgery in the USA shows a twofold variation between the lowest and the highest quintiles, which surprisingly is not related to complication rates. Rather it is related to the way complications are managed. Surgeons, it seems, kill more patients after their operations than during. http://content.nejm.org/cgi/content/abstract/361/14/1368

Lancet 3 Oct 2009 Vol 374
1171 Of all the things to UPLIFT sales for Boehringer Ingelheim and Pfizer Pharmaceuticals, a disease-modifying agent for chronic obstructive pulmonary disease would have to come top. They ran a trial of this name for tiotropium in various grades of COPD, carefully prespecifying their subgroups so they could not be accused of cheating if one of them turned out to have a good result. In patients with stage II COPD using the GOLD classification this proved to be the case – a reduction in decline of postbronchodilator FEV1 and better ratings on the St George’s Respiratory Questionnaire compared with placebo. So for patients with early and mild symptoms, tiotropium may have a place. But whether this really warrants a population-wide effort to identify early COPD, as the editorial states, is more debatable. There is still a lot more to be done in promoting smoking cessation, the only intervention that will really affect COPD, plus cardiovascular disease, plus lung cancer; and a lot else.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)61298-8/abstract

Thursday, 1 October 2009

HEART ARTICLES

JAMA 16 Sep 2009 Vol 302
1195 Another study from the indefatigable American Heart Association team looks at cardiopulmonary resuscitation outcomes in the USA. (Some readers will realise that when I use the word indefatigable it’s a sort of code name for Harlan Krumholz). If you are black, your chances of making it out of the hospital door alive are about 20% worse than for whites, and most of this is explained by the performance of the hospitals you are likely to get admitted to. Don’t socialize American medicine! Praise the Lord and shoot the moose.
http://jama.ama-assn.org/cgi/content/abstract/302/11/1195

BMJ 26 Sep 2009 Vol 339
735 A lot of women get pregnant while taking serotonin reuptake inhibitors for depression, and many of them continue taking them. This will probably remain the case following this comprehensive cohort study from Denmark, covering nearly half a million births from 1996 to 2003, even though it shows an overall doubling of septal heart defects in babies born to women taking SSRIs. The highest risk seems to come from sertraline and the lowest from fluoxetine. There is no additional risk of other major congenital malformations. It is unclear whether discontinuing these drugs after conception will make much difference.
http://www.bmj.com/cgi/content/full/339/sep23_1/b3569

736 Now for the thigh circumference paper which caused much furrowing of brows when it first appeared on the BMJ website. Denmark is famous for its hams but if these diminish below a certain size in humans of both sexes, then the risk of heart disease and premature death goes up steeply, irrespective of other biometrics. Odd. Strange. Queer. Puzzling. Your guess is as good as mine.http://www.bmj.com/cgi/content/full/339/sep03_2/b3292

Arch Intern Med 14 Sep 2009 Vol 169
1484 If you are going to use thrombolysis for occlusive stroke, the sooner you do it the better: if this sounds obvious now, consider how unobvious it sounded ten years ago, or even five to most people in the street. The number needed to treat is still very high, and if this German cluster-randomised trial of a public awareness campaign had used a hard end-point, like overall reduction of disability or death from stroke, it would have had a zero result. Instead, it yielded a 27% increase in women with stroke reaching hospital within three hours. I think that we can conclude that personal letters with bookmarks and stickers are not a cost-effective basis for a stroke awareness campaign.
http://archinte.ama-assn.org/cgi/content/abstract/169/16/1484

1491 We move now to Adelaide, a city of free Australian settlers named after Her Serene Highness Princess Adelaide of Saxe-Meiningen. “She is doomed, poor dear innocent young creature, to be my wife”, wrote the vast libidinous Prince George, heir to the British throne, in 1818. In fact they were improbably happy together, living with a selection of the prince’s illegitimate children in Hanover, though all Adelaide’s pregnancies miscarried or the babies died early. So it came about that this five-syllable German girl’s name became a three syllable south Australian place name, scene of the CADENCE study looking at the prevalence of weekly angina among patients in primary care. Chronic stable angina is something we tend to consign to repeat prescribing and once a year nurse checks, but one in three of these patients gets an attack at least once a week, and there is probably room for better audit and control. After all, we do not want these patients to get cremated, as Beethoven implies his heart will be in the final cadence of Adelaide:Eine Blume der Asche meines HerzensDeutlich schimmert auf jedem Purpurblättchen:Adelaïde!
http://archinte.ama-assn.org/cgi/content/abstract/169/16/1491

1500 If I had advanced heart failure, I would want to keep open the exit of sudden arrhythmic death, knowing what the other exit is like. But plenty of HF patients, especially in the USA, have been expensively fitted with implantable cardioverter-defibrillators to prevent such an outcome. This meta-analysis shows that they do not in fact reduce all-cause mortality in women with advanced HF. The shocking truth.
http://archinte.ama-assn.org/cgi/content/abstract/169/16/1500

Friday, 25 September 2009

WOMEN, HEARTS & DIABETES

Arch Intern Med 14 Sep 2009 Vol 169
1484 If you are going to use thrombolysis for occlusive stroke, the sooner you do it the better: if this sounds obvious now, consider how unobvious it sounded ten years ago, or even five to most people in the street. The number needed to treat is still very high, and if this German cluster-randomised trial of a public awareness campaign had used a hard end-point, like overall reduction of disability or death from stroke, it would have had a zero result. Instead, it yielded a 27% increase in women with stroke reaching hospital within three hours. I think that we can conclude that personal letters with bookmarks and stickers are not a cost-effective basis for a stroke awareness campaign.
http://archinte.ama-assn.org/cgi/content/abstract/169/16/1484

Ann Intern Med 15 Sep 2009 Vol 151
386 When reading papers with the words “net value of health care” in the title, it is always worth remembering that the best way to ensure value in health care is to ensure a swift death for everyone who is not working, especially the elderly. However, this Mayo Clinic study of the net value of health care for patients with type 2 diabetes, 1997 to 2005, is somewhat less drastic in its approach, and bases its figures on the reduction in spending on coronary heart disease in the UKPDS tight control cohort. These were patients in their early fifties with new-onset diabetes, so they don’t actually tell us anything about the economics of treating people with type 2 diabetes in the age beyond retirement. Just as well, really. http://www.annals.org/cgi/content/abstract/151/6/386
394 The thing that goaded me into writing an editorial on tight control of glucose in longstanding type 2 diabetics last March was the silence of diabetologists following the ADVANCE and ACCORD studies in June the previous year, plus the VADT study which told the same story and was published in January 2009. These were prospective randomised trials designed to answer much the same question, and they all gave the same answer: intensive glucose control in established type 2 diabetes does not reduce overall cardiovascular mortality and increases the risk of severe hypoglycaemia. Since then a number of meta-analyses have appeared, this being the latest. These include long-term observational data from UKPDS, which was not designed to answer this question; The Lancet , one also included data from a wildly irrelevant study, and there is a further one waiting in the wings on the Diabetologia website. As a study in the sociology and psychology of medical practice, this is quite interesting and a little dispiriting, but as far as treating patients goes, the message could not be simpler. For type 2 diabetics a few years into the disease process, there is no point aiming for an HbA1c under 7.5%. There is a tendency to fewer non-fatal CV events and perhaps some renal protection for a tiny number, but overall it makes no difference and causes hypoglycaemic episodes, which can cause brain damage. Cognitive impairment should be an end-point in future studies.
http://www.annals.org/cgi/content/abstract/151/6/394

BMJ 5 Sep 2009 Vol 339
And now to the vexed question of which drugs should be used for type 2 diabetes, where nothing quite works out as it should. For example, the thiazolidinediones as a group have a favourable effect on HbA1c , on lipids and on measures of insulin resistance. Rosiglitazone has a greater effect on peroxisome proliferators activated receptors (PPARs) than pioglitazone and by rights it should be the better drug. Both cause an equal amount of peripheral oedema. But in fact pioglitazone causes less heart failure than rosiglitazone and a big Canadian cohort study has a better mortality record as well. Yet the accompanying editorial sounds a note of caution about the data we have at present, and warns us against too much enthusiasm for any of the newer incretin pathway drugs too. The fact is that in diabetic therapeutics, as in most of medicine, you just can’t tell what is going to happen until enough of it has happened.
http://www.bmj.com/cgi/content/abstract/339/aug18_2/b2942

JAMA 2 Sep 2009 Vol 302
947 Funny how medical terms change meaning: to an old pedant like me, acute coronary syndromes mean any acute syndromes caused by the coronary arteries, including myocardial infarction and sudden death, but it seems that JAMA readers automatically assume that it only means coronary syndromes without ST elevation. With these latter syndromes there is still room for debate about the relative merits of immediate versus delayed intervention, the key question in this multicentre French trial. Patients with non-ST elevation ACS were randomised to get their angiographic intervention either immediately (mean 70 minutes) or on the next working day (mean 21 hours) and the outcome was myocardial infarction measured by troponin 1. There was no difference between groups in this important short-term outcome.
http://jama.ama-assn.org/cgi/content/abstract/302/9/947

NEJM 3 Sep 2009 Vol 361
980 A Dutch study shows that patients undergoing vascular surgery do better if they take a perioperative high dose statin. The rate of myocardial infarction and cardiovascular death within 28 days was halved with fluvastatin 80mg. More evidence that the protective effect of statins is not mediated through long-term effects on lipids.
http://content.nejm.org/cgi/content/abstract/361/10/980
990 I have previously described coronary artery calcium screening as the payment of large sums to receive high doses of ionising radiation in return for an increase in anxiety. This article on its place in cardiovascular prevention strategies reaches much the same conclusion, but I’m sure this will do nothing to dent its popularity with the rich worried well.
http://content.nejm.org/cgi/content/extract/361/10/990