Researchers document post-transplantation mortality rates in adults with congenital heart disease
Davies R. Circulation. 2011;123;759-767.
Following a high short-term mortality, patients with congenital heart disease had better late survival after heart transplantation, according to researchers.
The study involved 41,849 patients older than 18 years who were listed for primary transplantation between 1995 and 2009. Investigators compared patients with a history of congenital heart disease (CHD; n=1,035) with those with non-CHD causes (n=40,814). Of the study patients, 26,055 reached transplantation, with 10,484 having and 15,571 not having prior sternotomy.
According to study data, survival was comparable between CHD and non-CHD arms, although among CHD patients, mechanical ventricular assistance was not linked with superior survival to transplantation. Also reported among CHD patients was a higher likelihood of having a BMI of less than 18.5 at transplantation, fewer comorbidities and a younger age.
Researchers looked at early mortality rates and found a significantly higher rate among patients with CHD in both the reoperation arm (18.9% vs. 9.6%; P<.0001) and the non-reoperation arm (16.6% vs. 6.3%; P<.0001), despite a nearly equal mortality rate at 10 years (CHD, 53.8% vs. non-CHD, 53.6%).
In the study’s clinical perspective, the researchers wrote that improving the understanding of the differences between CHD and non-CHD patients may enable improvements in the outcomes of this increasingly important population.
“The increasingly common transplantation of patients with complex CHD may result in particularly high post-transplantation mortality, and centers performing these transplantations should proceed with caution,” they said. “Collection of data specific to the CHD population, including accurate congenital diagnoses, is essential to better understand and improve the outcomes with transplantation in this population.”
The paper by Davies and colleagues is a significant review of over 1,000 congenital heart disease patients who develop advanced HF that requires cardiac transplantation. This is the first look into these patients in a large registry from the United Network for Organ Sharing. It is noteworthy that patients with CHD are living longer and as many as 10-20% of CHD patients will eventually require cardiac transplantation. As seen in previous smaller studies, early mortality after transplant is high but it is comforting to know (from this study) that late survival is better than that among non-CHD patients. The CHD patients are, in general, younger and I believe they are more resilient to recover from complications. A major limitation from this study is that the specific CHD abnormality was not available through the UNOS Registry. Therefore, accurate outcomes of specific CHD diagnoses was not possible to determine. This will be important for future studies as specific CHD diagnoses may have different outcomes.
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Registry data highlight importance of clinical conditions in treating CTO lesions
Cardiovascular Research Technologies 2011
Cardiovascular Research Technologies 2011
New one-year data from the IRCTO registry have suggested that outcome of treatment of chronic total occlusion lesions was related to patient clinical conditions as opposed to strategy of treatments in Italy where prevalence of these lesions is roughly 12%.
According to presenter Alfredo R. Galassi, MD, director, Diagnostic and Cardiovascular Interventional Laboratory, Ferrarotto Hospital University, Catania, Italy and investigator on the trial, the incidence and prevalence of coronary chronic total occlusion [CTO] lesions, as well as the demographic characteristics of patients affected by CTO’s, are unknown.
“The aim [of the study] was to assess the prevalence, demographics, clinical characteristics and therapeutic strategy of patients with CTOs in order to improve the management of patients with chronically occluded coronary arteries,” he said.
The study included 1,777 patients from 12 centers throughout Italy from the Italian Registry on Chronic Total Occlusion (IRCTO). The patients had at least one CTO in a main coronary artery for greater than 3 months duration with vessel size greater than >2.5 mm at coronary angiography.
Overall, investigators reported 1,968 CTOs among patients. One month unadjusted clinical outcome did not result in a statistically significant difference in death, stroke or MI, among patients treated with percutaneous coronary intervention, CABG or optimal medical therapy. However, at 12 months, compared with optimal medical therapy, rates of death and acute MI but not stroke were significantly less in patients treated with PCI.
According to univariate analysis, predictors of hard events included ejection fraction <35% (OR=1.76; 95% CI, 1.12-2.77), multivessel disease (OR=2.07; 95% CI, 1.13-3.80) and age (OR=1.06; 95% CI, 1.04-1.08).
Additionally, concluded Galassi, patients with a successful PCI had a better outcome than those without one (P=.03). – by Brian Ellis
For more information:
Galassi A. Presented at: Cardiovascular Research Technologies 2011. Feb. 27-March 1, 2011; Washington, D.C. .
There is now a remarkable consistency from data from Italy. In fact, this represents, by my count, the 12th study that would suggest through indirect comparison and minding the biases both with regard to treatment and selection of these patients that there is a consistency across these observational studies demonstrating improved survival and freedom from adverse events over an immediate long-term follow-up—follow-up, in some observation studies, that extends now beyond many years.
That said, however, we still need a large randomized trial that would help refine the benefit of CTO revascularization from hard clinical endpoints. However, to design a trial based on hard clinical endpoints like mortality, you have to think about the limitations of sample size and statistical power. And probably what is more relevant is a composite that would reflect not only mortality in itself but avoidance of future ischemic events and rehospitalization and very importantly a benefit with regard to quality of life.
It is noteworthy, however, that in this Italian registry there is a lower representation of patients with multivessel disease and patients with reduced left ventricular function in part reflecting clinicians’ discretion to refer patients to surgery or to treat them with medical therapy alone. But it’s important to realize that these are some of the patients who derive the greatest relative treatment effect from CTO revascularization.