TLDR;
This podcast episode of "This Week in Cardiology" discusses several key topics: long-term outcomes of the Evolute low-risk TAVI trial, the ethics of unilateral DNR orders, the ineffectiveness of targeted hypothermia after cardiac arrest, a novel transcatheter shunt system for heart failure, and the potential of GLP-1 agents as anti-arrhythmic drugs for atrial fibrillation. The analysis of the Evolute trial raises concerns about valve reliability and reintervention rates, while the discussion on DNR orders highlights the need for better documentation and re-evaluation processes. The episode also touches on the importance of sham-controlled trials for subjective endpoints and the promising role of GLP-1 drugs in managing atrial fibrillation by promoting weight loss and improving cardiac health.
- Six-year outcomes of the Evolute low-risk TAVI trial show potential concerns regarding valve reliability and reintervention rates compared to surgical AVR.
- Unilateral DNR orders require better documentation and regular re-evaluation to ensure appropriate patient care.
- Targeted hypothermia after out-of-hospital cardiac arrest continues to show no benefit, questioning its continued use.
- A novel transcatheter shunt system for heart failure is undergoing trials with a sham control arm to ensure objective assessment.
- GLP-1 agents show promise as anti-arrhythmic drugs for atrial fibrillation, particularly in obese patients, due to their weight loss and cardiac benefits.
Introduction [0:00]
John Mandola from the heart.org Medscape Cardiology introduces the topics for this week's cardiology update, which include longer-term data from the Evolute low-risk TAVI trial, a meta-analysis, DNR orders, targeted hypothermia, evidence regarding heart failure, GLP1 agents as AIB drugs, and the evaluation of patients with chest pain.
Evolute Low-Risk TAVI Trial: Six-Year Outcomes [0:42]
The six-year outcomes of the Evolute low-risk TAVI trial, initially published in the New England Journal of Medicine in 2019, reveal some surprises. The trial involved 1468 patients with severe aortic stenosis randomized to self-expanding Medtronic TAVI valve versus surgical AVR. While initial results at two years showed TAVI was non-inferior to surgery, longer-term data presents a more complex picture. The primary composite endpoint of death or disabling stroke was analyzed using superiority testing with Kaplan-Meier estimates, showing a 23.3% rate for TAVI versus 20.4% for surgery, a non-significant difference. However, at seven years, mortality rates diverged, with 27.7% for TAVI and 23.9% for surgery, while cardiovascular mortality remained similar.
Reintervention Rates and Exploratory Analysis [3:17]
A significant finding was the divergence in reintervention rates, with TAVI showing 9.8% versus 6.0% for surgery at seven years (p=0.02). Reintervention for TAVI can be serious, especially if surgical, with observational data showing high death rates for TAVI valve replacements. The causes of reintervention differed, with more TAVI patients requiring reintervention for aortic insufficiency. An exploratory analysis suggested a higher reintervention rate in patients who had off-guidance post-dilation, but this association may be confounded by the reasons for performing the dilation.
Neutral Perspective on TAVI Outcomes [6:08]
From a neutral perspective, it's important to consider the patient's view, as some may favor the less invasive TAVI procedure despite a slightly worse outcome at 10 years due to the quicker recovery. However, younger patients may prioritize long-term mortality differences. TAVI outcomes may vary depending on the valve type, with higher reintervention rates seen with Evolute valves. The death signal is also concerning, with a nearly 3% higher death rate in the TAVI arm. The analysis of Kaplan-Meier curves may be affected by non-proportional hazards, and the change to a superiority testing strategy without prespecification raises questions.
Meta-Analysis and UK TAVI Trial [9:58]
A BMJ Heart meta-analysis showed a 99.3% posterior probability that SAVER was superior to TAVI for mortality at 5 years. The UK TAVI trial also presented less favorable results for TAVI at five years, with a statistically significant increase in stroke. These findings suggest caution in using TAVI for low-risk patients due to concerns over valve reliability, reintervention, and higher stroke rates, emphasizing the need for shared decision-making with patients.
DNR in the Hospital: Unilateral DNR Orders [12:39]
A viewpoint paper in JAMA discusses the ethics of unilateral DNR orders, which are DNR orders that do not require patient or surrogate consent. These are often used when CPR is deemed futile or inappropriate. The authors argue that documenting unilateral DNR decisions as standard DNR orders is unethical because it obscures the unilateral aspect of the decision. They propose creating a unique unidirectional DNR order that requires regular re-evaluation of the patient's code status and designates whether patient or surrogate disagreement exists. This would increase visibility and potentially normalize the use of unilateral DNR decisions.
Importance of Addressing Bad Deaths [16:24]
The importance of this topic is highlighted because contributing to bad deaths is a significant stress for healthcare professionals. Interventional cardiologists often face situations where further resuscitation is not beneficial and may be harmful. Unilateral DNR orders may be necessary when there is no family or the family is unsure. The ethical tension in this is questioned, comparing it to the clinical decision to stop CPR when it is not working.
Failure of Targeted Hypothermia in the ICU [18:02]
The discussion moves to the failure of targeted hypothermia in the ICU. Despite years of evidence against it, targeted hypothermia persisted as a standard practice after out-of-hospital cardiac arrest. A two-year follow-up from the TTM2 trial, published in JAMA Neurology, showed no differences in neurologic outcomes between targeted hypothermia and targeted normal thermia. This raises questions about the money wasted and harm caused by aggressive cooling.
Good News in Heart Failure Evidence [19:48]
Ryan Tedford shared news of a trial design and rationale paper for the Aperture transcatheter shunt system, a left atrial to coronary sinus (CS) shunt. The procedure involves accessing the right internal jugular vein, entering the CS, and creating a shunt between the left atrium and the CS. The Alt Flow 2 trial will include a sham control arm with blinding of patients and doctors, which is crucial for assessing subjective endpoints.
GLP1 Agents as AF Drugs [21:54]
An observational study in Europace from Milan, Italy, examined the use of semaglutide in obese patients undergoing first-time catheter ablation for paroxysmal atrial fibrillation (PAF). Patients who initiated semaglutide had a significantly higher freedom from recurrence of AFib at 18 months compared to controls. Weight and BMI decreased significantly in the semaglutide group. While the study is methodologically weak, the findings are mechanistically plausible, as weight loss is known to improve AF outcomes. The speaker expresses optimism that GLP-1 drugs may become one of the best anti-arrhythmic drugs ever developed.
Conclusion [24:33]
In conclusion, the speaker expresses gratitude to the listeners and encourages them to provide ratings, reviews, and feedback.