Sunday, February 15, 2026
Sham placebo surgery or device intervention ProJR: From a random riddle driven journal club
[16/02, 09:20]hu2: Riddle driven journal club: 👇
Riddle answers from global faculty online:
[16/02, 08:50]hu1: MORNING MEDICAL RIDDLE...........Subject: Cardiology
[16/02, 08:53]hu3: Device closure for vsd
Or ASD?
Lowers the pressure is the clue methinks!
[16/02, 08:53]hu4: Device closure of septal defects (ASD or VSD)
16/02, 08:56]hu5: ASD device
[16/02, 09:42]hu6: Is it ASD
Or VSD
Or any device ASD VSD
As the riddle talk of continuous flow!
[16/02, 09:20]hu2: Riddle driven journal club: 👇
"total of 442 patients were in the group undergoing device closure, whereas 154 patients were in the surgical group. The median age was 9.8 years for the device group and 4.1 years for the surgical group (p < 0.001). In the device group, 395 (89.4%) patients had a single ASD; in the surgical group, 124 (80.5%) (p = 0.008) had a single ASD. The size of the primary ASD was 13.3 ± 5.4 mm for the device group and 14.2 ± 6.3 mm for the surgery group (p = 0.099). The procedural attempt success rate was 95.7% for the device group and 100% for the surgical group (p = 0.006)."
Unquoted from the full text here: https://www.jacc.org/doi/full/10.1016/S0735-1097(02)01862-4#
Provocative Socratic query to stoke some fire into the journal club above:
The above procedures, umbrella or no umbrella (surgery) are all a sham.
The same patients would have had an uneventful life otherwise!
[16/02, 09:26]hu2: 👆@hu3, I guess we can't answer the question at the bottom here because no one would have done an RCT comparing the above interventions to sham interventions?
Would be great to know more about sham surgery or device based interventions in RCTs such as available in papers such as these: https://pmc.ncbi.nlm.nih.gov/articles/PMC10288945/
[16/02, 09:27] PaJR Health Bot Feb 26: The Socratic query you’ve posed strikes at the heart of "Evidence-Based Medicine" versus "Biomechanical Assumptions." You are correct that for many structural heart interventions, we lack the "Gold Standard" of a sham-controlled Randomized Controlled Trial (RCT).
The paper you referenced (Tran & Prasad, 2023) highlights a sobering reality: in orthopedic research, when sham controls are actually used, **71% of the surgical interventions fail to show superiority over the sham procedure.**
Below is a breakdown of the current landscape regarding sham controls in device and surgical interventions, specifically addressing your query on Atrial Septal Defect (ASD) closure.
**THE SHAM GAP IN CARDIOLOGY AND ORTHOPEDICS**
🔹 **THE ORTHOPEDIC PRECEDENT**
The paper by Tran and Prasad (PMC10288945) argues that procedures like Total Knee Arthroplasty (TKA) are performed millions of times based on "circumstantial evidence." They propose a "surgical atlas" for a sham knee surgery to prove whether the benefit comes from the prosthesis or the intensive perioperative rehabilitation and placebo effect.
🔗 Visualizing the randomized sham-controlled trial in orthopedic research - https://pmc.ncbi.nlm.nih.gov/articles/PMC10288945/
🔹 **THE ASD CLOSER DILEMMA**
The JACC study you cited (Du et al., 2002) was a **nonrandomized** trial. It compared Amplatzer Septal Occluder (ASO) devices to surgery. While it showed high success rates (95.7% for devices vs. 100% for surgery), it did not include a "no-intervention" or "sham" arm.
💡 **Clinical Logic:** The medical community assumes that a left-to-right shunt causes irreversible pulmonary hypertension and right heart failure over decades. Therefore, a sham arm (where a catheter is inserted but no device is placed) is often deemed "unethical" by Institutional Review Boards (IRBs) because it denies a "proven" corrective treatment.
🔹 **SHAM SUCCESSES IN CARDIOLOGY**
While ASD closure lacks a sham RCT, other "structural" cardiac procedures have been debunked by them:
1. **ORBITA Trial:** Percutaneous Coronary Intervention (stenting) for stable angina was compared to a sham procedure. The result? Stenting did not increase exercise time more than the sham.
2. **SYMPLICITY HTN-3:** Renal denervation for hypertension failed to beat the sham control, despite years of "successful" observational data.
**SOCRATIC CHALLENGE: IS IT ALL A SHAM?**
Your provocation that "the same patients would have had an uneventful life otherwise" touches on the concept of **Overdiagnosis and Overtreatment**.
🔹 **THE NATURAL HISTORY ARGUMENT**
Many small ASDs (especially <10mm) are indeed asymptomatic for life. However, the "Riddle" in the journal club points to the "corrosive flow" (hemodynamic shunting). The intervention is based on the *preventative* model—stopping the "healthy glow" of the heart from fading into pulmonary hypertension in the 4th or 5th decade of life.
🔹 **THE ETHICAL CATCH-22**
We cannot answer your question with an RCT because:
1. **Equipoise:** Most cardiologists no longer have "equipoise" (uncertainty); they are convinced the shunt is harmful.
2. **The "Surgical Imperative":** Once a mechanical "hole" is identified, the biomechanical urge to "plug it" is nearly impossible to resist without a mandate for sham trials.
**SUMMARY OF EVIDENCE RECORDS**
📋 **PaJR Records & Academic Portfolios**
1. Visualizing the randomized sham-controlled trial in orthopedic research - https://pmc.ncbi.nlm.nih.gov/articles/PMC10288945/
2. Comparison between transcatheter and surgical closure of secundum atrial septal defect - https://www.jacc.org/doi/full/10.1016/S0735-1097(02)01862-4
3. Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Repair (A rare example of a randomized trial for iatrogenic ASDs) - https://www.jacc.org/doi/10.1016/j.jcin.2021.09.023
💡 **Insight:** Until regulatory bodies mandate sham-controlled trials for high-risk devices (similar to placebo requirements for drugs), we will continue to rely on the "biomechanical model" which, as history shows, is frequently vulnerable to the placebo effect.
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