Feeds:
Posts
Comments

Posts Tagged ‘acc aha esc’

Caution: Harsh language & Unscientific truths

It is a pattern out there, rolled out periodically in cardiac- pharma literature . It happened for Digoxin. They have been trying to do this to beta blockers for quite some time. They successfully ditched beta blockers in systemic hypertension with synthesized evidence. Mind you, BBs are the only drug that received a Nobel Prize for its invention, and its role in post-MI protection is well established.

The script is well written. Trying to ring a death knell for cheap and established medical therapeutic norms, citing lack of evidence. It is done based on some non-sensical study designs called Non-Inferiority Trials. (Tannock I, Buyse M, De Backer M et al.The tyranny of non-inferiority trials The Lancet Oncology, 25, e520-e525 Now, powerful cartels want to get rid of BBs in  post-MI ecosystem. REBOOT, REDUCE-AMI, ABYSS all were done with fixed ideas. Of course, ABYSS didn’t follow their agenda. Now, a  the latest trial has come out with a magical name SMART – DECISION.

Read this paper https://www.nejm.org/doi/full/10.1056/NEJMoa2601005

One famous statistician said, non-inferiority study concept is foundationally flawed. Hence, it is generally not worth reviewing them, as most conclusions are deemed to be wrong and not scientifically consumable. Still, looking beyond the trial design, three important flaws are obvious in SMART-DECISION’ trial , which argues for beta-blocker discontinuation after MI.

The study population is highly selected (median 4.7 years 98% revascularized; median LVEF 59%). The study advocated discontinuation among long-term accrued beneficiaries of BBs rather than typical 6–36-month post-ACS patients. Physician-driven HF hospitalization amplifies open-label bias. A wide non-inferiority margin (HR upper CI <1.4) plus low events (132 total) leave it underpowered, unable to exclude modest 15–25% harm (7.2% vs 9.0%).

Final message

In science, we need to be right first … being polite is optional.

When big science tries to corrupt our minds, what should we do? Let us continue with our conscience and follow the instinct and work for the welfare of our patients. We know the healing power of BBs. Let us be cautious and alert. Never allow wayward science to intrude upon our minds to take STUPID DECISIONS and defame the OMT in CAD.

Postamble

A newchallenge to take on

Fact : There is no published RCT that proves diuretics improve mortality and survival in heart failure.

Action requested : Let all evidence-based cardiologists withhold injections of Furosemide or Torsemide when they encounter their next patient with acute heart failure and pulmonary edema.

Read Full Post »

Cardiologists have always struggled to classify, assess, and grade one important valve disease, which is Mitral regurgitation. While valve replacement is the ultimate treatment, the timing of MVR is still a big debate. Apart from valve replacement, valve repair is a strong contender in selected patients. In recent times, cardiologists have made great strides to grab MR patients from cardaic surgeons. MitraClip, a percutaneous edge stitching , is possible with a varying degree of success.

Mitral valve edge-to-edge repair (MEER) is an interventional clone of Alfieri surgery that has shown conflicting results in the MITRA-FR and COAPT studies. The reason for this discrepancy in the MITRA-FR population is that they had larger-sized ventricles, which continued to pose challenges for the clip, which is focused only on the leaflets.

A new subdivision of secondary MR

Now, some of the cardiologists want to classify SMR/FMR into Proportionate vs Disproportionate MR. It may not be a great innovation, but it sub-divides secondary MR for optimal therapy. It simply says if LV dilation is significant, clipping the leaflet alone will not be sufficient; it would rather need an annular restriction either at the time of the index clip procedure or in due course. While Disproportionate MR implies, it is more of a leaflet coaptation defect, dominating over annular contribution.

Who proposed this ? What is the implication?

It is an afterthought, I think, from the makers of annular restriction device makers. MEER is found to be less effective in proportional MR.The Carillon device is a new arrival to tackle secondary MR .It is actually a wire that forcibly tightens the AV annulus inserted through coronary sinus . This modality takes advaantage of the aantomical proximity of coronary sinus to mitral annulus. Coronary sinus encircles and from a virtual wall along significant circumference of mitral annulus.

Unlike mitraclip, the Carillon device is claimed to tackle secondary MR irrespective of whether it is proportional or disproportional. It also has the potential to reduce LV dimensions in the long run. We have another device called IRIS-Millipede (to compete with Carillon).

Front. Cardiovasc. Med., 20 November 2020
Sec. Structural Interventional Cardiology
Volume 7 – 2020 | https://doi.org/10.3389/fcvm.2020.576058

Final message

We are free to have as many classifications in MR (Primary, Secondary, Functional, Atrial MR, & now Proportionate Disproportionate.) It is not the aim to bring up a rivalry between leaflet vs annular intervention. Ultimately, the most powerful component of the mitral valve apparatus, i.e., the LV muscle that matters.

I would request the esteemed researchers in MR ,not to keep EROs, regurgitation fractions, or chamber dimensions as primary markers of success of a device. Having strong clinical outcomes as the endpoint should be made mandatory, i.e., prolonging good quality of life and survival (But, the reality can bite hard. Someone told me, walking 20 meters extra in a 6-minute walk test is enough to get device approval from the authorizing entities.)

Final message

1.Grayburn PA, Sannino A, Packer M. Distinguishing Proportionate and Disproportionate Subtypes in Functional Mitral Regurgitation and Left Ventricular Systolic Dysfunction. JACC Cardiovasc Imaging. 2021 Apr;14(4):726-729. doi: 10.1016/j.jcmg.2020.05.043. Epub 2020 Aug 26. PMID: 32861653.

Postamble : A surgeons perspetive

While we debate about devices, the true benefits may lie elsewhere. A good MVR done by a mitral heart surgeon is the need of the hour. Says this paper from a top heart surgeon in India. Yadava OP. Disseminating valve repairs – a clarion call. Indian J Thorac Cardiovasc Surg. 2020 Jan;36

Read Full Post »

World heart day is being celebrated every year on September 29th ,Initiated by the World heart federation with a genuine purpose, vision & goal. It has become big hit in recent times. In India, the theme has captured the imagination of the main stream media . Every one wants to propogate a message. I am not an exception. Please bear with this skewed message “One for the patients and the other for the self” !

Read Full Post »