US-based clinical registries, such as the National Cardiovascular Data Registry and Get With The Guidelines, have been instrumental in identifying and addressing gaps in quality of care for patients across the country. It is fascinating to see approaches in other countries who have developed nationwide clinical registries, inclusive of all citizens. In Sweden, clinical registries like SCAAR and SWEDEHEART, have not only been used to describe trends in nationwide clinical outcomes but are now being used as a platform for the conduct of randomized trials. With rich characterization of patients and longitudinal followup, clinical registries can be used to identify, enroll, and follow patients randomized to treatments or strategies of care that need more investigation. These innovative “randomized clinical registry studies” are being conducted in the US as well. We need more of them.
Second year cardiology fellow Matthew Sherwood asks Sunil Rao, Director of Durham VAMC Cardiac Catheterization Lab, about the latest science coming up at ACC 12 and how fellows can take advantage of it.
In a study from the Cardiovascular Patient Outcomes Research Team (C-PORT), investigators found that patients who had elective PCI at hospitals without on-site surgical backup fare no worse than those with surgical backup. Lead investigator Dr. Thomas Aversano said, “We do not support the spread of angioplasty to every hospital in the United States. However, it can be burdensome and costly for all medical centers to have cardiac surgeyr capabilities. And it doesn’t make sense to create more surgical programs just to support the angioplasty programs.” The new ACCF/AHA guidelines on PCI and CABG released last week did update the recommendations on elective PCI without on-site surgery, upgrading this to class IIB from class III. In other words, it is now reasonable per the guidelines to consider elective PCI without surgical backup. It will be interesting if the guidelines are updated further in light of the findings announced today.
Dr. Robert Harrington discussed the results at an AHA press conference:
Zubin Eapen catches up with John Vavalle to discuss a novel, reversible anticoagulation system for non-ST elevation acute coronary syndromes. Among many potential benefits, fellows should imagine how much better their lives could be with earlier sheath pulls!
When it comes to complex decisions, such as whether to undergo PCI, health care providers have been unable to educate patients sufficiently to empower them in the decision making process. Dr. John Spertus, professor at the University of Missouri, presented a novel program, PRISM, which generates personalized consent forms using patient-specific risk estimates. Dr. Manesh Patel, who served as the discussant, shares his thoughts at today’s press conference.
Two questions that has challenged physicians for years.
This NHLBI sponsored trial compared CABG with medical therapy alone in 1212 patients with coronary artery disease amenable to surgery with a left ventricular ejection fraction < 35% and found a non-significant reduction in the risk of the primary end-point of death with CABG (HR with CABG, 0.86; 95% CI: 0.72-1.04; P=0.12) and a significant 26% reduction in the risk of death or hospitalization for cardiovascular causes (HR with CABG, 0.74; 95% CI, 0.64 to 0.85; P<0.001).
Provocative were also the findings of the large myocardial viability substudy, which involved almost half of the enrolled patients. Contrary to popular beliefs, SPECT did not identify patients who benefit from surgery.
Both the main study and the substudy were published simultaneously on the New England Journal of Medicine accompanied by an editorial defining the studies as “illuminating” and “extremely well conducted.”
In a session moderated by Duke’s Chief of Pediatric Cardiac Surgery Robert DB Jaquiss entitled “Surgical Outcomes in Congenital Heart Disease”, DCRI’s Sara Pasquali presented the results of a retrospective multi-institutional evaluation of patient risk status, center volume, and outcome following the Norwood operation. Dr Pasquali’s use of the Society of Thoracic Surgeons Congenital Heart Surgery Database, currently the largest pediatric cardiac surgery database in the world with over 180,000 operations, allowed her to stratify patients into low medium and high risk categories based on pre-operative factors. She demonstrated that center volume was associated with mortality across all 3 pre-operative risk categories. However, only roughly 14% of the variance in mortality across centers could be explained by surgical volume.
Dr Pasquali concluded that a strategy based on evaluation of centers by outcome rather than volume is most likely to succeed in identifying practices resulting in improved survival of these high risk infants. Earlier, a poster session led by poster discussant Jeffrey P Jacobs from Saint Petersburg, Fl, displayed work by the Children’s Hospital of Boston on the importance of surgical technical performance on post operative outcomes, as well as a report from the National Quality Improvement Collaborative on the variation in pre- and intra-operative care of infants undergoing the Norwood operation. Overall, these 2 sessions highlighted the tremendous accomplishments and ongoing effort in the field of pediatric cardiac outcomes research.
One of the best parts about being a diagnostic cath fellow is learning the radial approach from Dr. Sunil Rao. We don’t have to pull sheaths and the patients clearly are as relieved as we are about that. But which approach is ultimately better for patients: radial or femoral?
Dr. Sanjit Jolly presented the results of the RIVAL trial which sought to evaluate the efficacy and safety of radial versus femoral access for PCI in patients with ACS managed with an invasive strategy. In total, 7021 patients with ACS were randomized to either radial or femoral access for angiography/intervention. The primary outcome was the composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft-related major bleeding up to day 30. There was no significant difference between the two approaches in the primary outcome (3.7% radial vs. 4.0% femoral; HR=0.92 (95%CI 0.72-1.17) p=0.50). The major take-home points from RIVAL are that radial access for angiography and PCI is safe and effective but does not appear to reduce MACE. Non-access related bleeding appears very important in predicting outcomes and obviously cannot be reduced by radial access. Practice makes perfect, as the best outcomes with radial access were at high-volume centers. Finally, patients greatly prefer radial access over femoral access and this can drive practice pattern. Today, we now have the largest data yet on radial vs. femoral. I am sure we have not heard the last word.
The ACC is now in full force. Check out what we did on Sunday:
Hot presentations in New Orleans! Using the NCDR CathPCI registry, DCRI Matt Brennan shed light on an important and controversial issue, PCI in patients with unprotected left main disease.
Using data on > 130,000 patients, he found that PCI is rarely performed in the US for this indication and death and major adverse events are common, influenced by patient and procedural characteristics rather than stent type (BMS vs DES).
Exciting data that we are certain will fuel the discussion. Download Matt Brennan’s slides.