Tag: septal reduction

Cytokinetics Teases Upcoming Phase 3 Aficamten Trial in nHCM

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A Phase 3 clinical trial aimed at the non-obstructed HCM population (nHCM) appears to be planned for Cytokinetics’ next-generation myosin inhibitor, aficamten.

Based on positive data from Cohort 4 of the Phase 2 REDWOOD-HCM trial, Cytokinetics is planning to soon launch a Phase 3 clinical trial for non-obstructed hypertrophic cardiomyopathy.  Non-obstructed HCM patients are a group whose only current treatment options are diuretics, beta-blockers, and other drugs used in the traditional heart failure setting.  In extreme cases, heart transplantation may be the only path available to these patients.

According to data presented on Sunday at the American College of Cardiology 72nd Annual Scientific Sessions (held in my beloved hometown of New Orleans, the city with the best and least heart-healthy food in the world), 41 patients with nHCM in the cohort showed improvement to both their NT-proBNP and troponin levels (both are biomarkers of heart wall stress seen in blood tests). And, the drug was generally well tolerated.

Separately, data was presented showing that obstructed HCM (HOCM) patients who took aficamten for a 48 week period showed significant improvement to their left ventricular outflow tract gradients (LVOT) while 88% of patients experienced improvement of at least one NYHA Functional Class.

All 19 HOCM patients enrolled in the trial who fit the eligibility criteria for septal reduction therapy (septal myectomy or septal alcohol ablation) at the start of the trial improved so much that they were no longer eligible after 48 weeks on aficamten.

It would be wonderful to have better options for the treatment HCM, so here’s hoping that aficamten continues down the road to FDA approval.

For more about aficamten, read these prior posts from HCMBeat:

2 Companies Testing Drugs for HCM

HCM Clinical Trials – the Latest News

The Future of HCM Care

Positive Signs from REDWOOD-HCM

Promising Data about Aficamten Presented at Meetings

More on Aficamten & Mavacamten from ACC 2022

Aficamten Updates from Cytokinetics

Aficamten Gets “Breakthrough Drug” Status from FDA

Cytokinetic’s Drug Aficamten & Upcoming HCM Summit – Interview with Dr. Martin Maron

Results Published from REDWOOD-HCM Phase 2 Trial

The Future of HCM Treatment

Septal Reduction – Not a One Size Fits All

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A recent article published in the European Journal of Cardiology Heart Failure compares septal myectomy to septal alcohol ablation. The paper goes through specific factors which make one procedure or the other more appropriate: individual anatomy and age being two .of the most important.

The article emphasizes that proper patient selection for either procedure is key.  Further, it emphasizes the necessity of having both procedures done at at high volume center in order to increase the odds of a successful procedure.

Seniors Do Well After Myectomy

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A recent study of Medicare patients conducted by doctors at the Cleveland Clinic found that senior citizens who underwent septal myectomy had better long term survival and did not need repeat procedures compared to those who underwent septal alcohol ablation.

And, despite the overwhelming evidence that septal reduction procedures performed at high volume centers have superior outcomes, 70% of septal reduction procedures are still being performed at low volume centers.

We need to spread the word that the success of septal reduction procedures is highly dependent on the experience and volume of the center!

VALOR-HCM Trial – Mavacamten vs. Septal Reduction Therapy – RESULTS ARE IN!

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The Phase 3 VALOR-HCM trial results were presented this morning at the American College of Cardiology annual meeting in Washington, DC by the principal investigator, Dr. Milind Desai of the Cleveland Clinic, and the results are good!

What was the VALOR-HCM study?

15 – 20  million people worldwide are estimated to have HCM, with 2/3 of this group having the obstructive form which can cause severe symptoms. Historically, these patients have been treated with medications approved for other conditions, and if those don’t relieve symptoms, they are referred on for septal reduction therapies (SRT) like alcohol septal ablation (a catheter based procedure) or septal myectomy (open heart surgery), which are invasive therapies requiring specialized care and which are not widely available.

The VALOR study was designed to compare mavacamten head to head with SRT to see if mavacamten could be a non-invasive treatment alternative for obstructive HCM.

Continue reading “VALOR-HCM Trial – Mavacamten vs. Septal Reduction Therapy – RESULTS ARE IN!” →

Experts Put Mavacamten in Perspective

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An article published today in Circulation by HCM experts Dr. Steve Ommen of Mayo Clinic and Dr. Martin Maron of Tufts Medical Center, discusses the prospective use of mavacamten as a treatment for obstructive hypertrophic cardiomyopathy. The doctors conclude that while mavacamten (assuming that it is FDA approved in early 2022) will have its place in the HCM tool kit, it should not replace septal reduction therapy for severe HOCM.

In particular, the article points out that the EXPLORER-HCM study showed modest improvements in symptoms and functional capacity (peak V02), comparable to those seen in the RESET-HCM study, which highlighted the ability of regular exercise to improve functional status in HCM.  

The article notes that there has not yet been a study directly comparing mavacamten with septal reduction therapies such as septal myectomy and alcohol septal reduction. The VALOR-HCM study, which is currently recruiting, will look at these therapies compared head-to-head.  It is noteworthy that the majority of patients in the EXPLORER trial had Class II heart failure and were not the more severely compromised Class III and IV patients most likely to benefit from myectomy or alcohol septal ablation.

This article compared historical myectomy data against the findings from EXPLORER, concluding that septal myectomy produces a better result for patients, with gradients abolished in more than 95% of patients compared to only 50% of patients with mavacamten.  And, the article points out that 25% of the patients in the EXPLORER trial continued to have left ventricular outflow tract gradients greater than or equal to 50mmHg, which still qualified them for septal reduction therapy.

Maron and Ommen’s take-home message is that mavacamten will be a welcome addition to the arsenal of HCM drugs and is potentially suitable for patients who do not have severe symptoms, who do not have access to septal reduction at a HCM specialty center, or who wish to avoid more invasive therapies.  It also may be used in the same way as disopyramide, to defer surgery by improving symptoms to a tolerable level.

Lastly, this article points out that there is a need for longer term follow up to study the effects of cardiac remodeling caused by mavacamten.

While it is wonderful to have options, it is important that patients and their medical team consider all available information, including potential benefit and risk, before moving forward with medical therapy. 

Could Septal Reduction Outcomes Vary by Gender?

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A retrospective analysis recently published in JACC: Cardiovascular Interventions suggests that that the risks of septal reduction therapy may differ for men and women.

In particular, the study found that the need for a pacemaker following septal alcohol ablation was almost 3 times more likely for a female than for a male.

The authors suggested that the reason for this difference may have been more advanced disease among female patients, and a higher instance of myocardial fibrosis and calcification.  

Whatever the reason, this is another factor for patients to consider before deciding which method of septal reduction is best for them.

The Future of HCM Care

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Dr. Stephen Heitner, together with his colleagues at Oregon Health & Sciences University, published an article last week in the European Journal of Heart Failure which gives a glimpse into the treatment of hypertrophic cardiomyopathy (HCM) in the future.  Although recent publications have stated that the majority of HCM patients today have a favorable prognosis when receiving appropriate treatment, a heavy disease burden continues to be placed upon patients.  Hence, better and more effective treatments for HCM are still needed in order to lessen this burden.

Continue reading “The Future of HCM Care” →

Should Alcohol Septal Ablation Be Considered for Younger Patients?

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Since the early 1960s, surgical septal reduction, also known as septal myectomy, has been used as a therapy for the treatment of obstructive hypertrophic cardiomyopathy. Pioneered at the National Institute of Health by cardiac surgeon Dr. Glenn Morrow, himself a HCM patient, septal myectomy has become a mainstay of the HCM treatment arsenal.

An alternative to septal myectomy, alcohol septal ablation (ASA), was first performed by Ulrich Sigwart in the United Kingdom at the Royal Brompton Hospital in London in 1994.

For many years, the indications for ASA procedures has been limited to older patients with obstructive HCM who were not otherwise healthy enough to undergo open heart surgery.  However, some doctors are now advocating to expand the indications for ASA to include symptomatic younger patients.

(For more information about myectomy and ASA,  click here and scroll to bottom of page).

Continue reading “Should Alcohol Septal Ablation Be Considered for Younger Patients?” →

Guest Blogger – Surgical Myectomy: A Twice in a Lifetime Experience – By Jill Celeste

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I have had the joy of being a Registered Nurse for over 40 years. I was born wanting to be a nurse and started bandaging teddy bears at the age of three. By the age of 5, I was creating “medicines” by spinning blades of grass mixed with clover flowers in the front wheel well of an upside down tricycle.

As I got older, I moved on to be a Candy Striper and a Nurse’s Aide, and then I went on to get my degree as a RN, a BSN, and MSN and became a teacher, administrator, and researcher. All of this cannot REALLY prepare you for; “Being on the other side of the bed” which is what happens when a health care professional who is used to caring for patients becomes a patient themselves. Continue reading “Guest Blogger – Surgical Myectomy: A Twice in a Lifetime Experience – By Jill Celeste” →

Alternative to Myectomy?

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Could this minimally invasive procedure prove to be a viable alternative to septal myectomy or alcohol ablation for septal reduction?

Doctors at Minneapolis Heart Institute are planning a larger, multi-center trial to test the viability of this procedure as a larger scale treatment for HCM.