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The Battle of the Vaccines: Pfizer/BioNTech vs. Moderna

Tampa, FL. On December 14th 2020, Tampa Bay healthcare workers received the first doses of the COVID-19 vaccine. In a pivotal moment in history, a life threatening disease was met with human ingenuity and determination, resulting in a highly effective vaccination. . . in fact multiple. Though we can’t choose which type of vaccine to receive, the availability of multiple options undoubtedly raises questions. How do the two vaccines really stack up?

Effectiveness

Both vaccines show similar effectiveness. Developed by the pharmaceutical company Pfizer and German firm BioNTech, the Pfizer/BioNTech vaccine has a 95% efficacy at preventing the COVID virus, 7 days after the second dose. On the other hand, the Moderna vaccine, developed by a Massachusetts biotechnology company, proved to be 94.1% effective, 14 days after the second dosage.

RNA Technology

The similar levels of effectiveness for both vaccines can be attributed to their usage of messenger RNA (mRNA) technology, which contains code for cells to generate a unique identifier on the COVID-19 virus body called “spike proteins.” Basically, the vaccine tells our cells to produce a unique part of the COVID-19. Our immune system, then, develops an immune response using specific immune cells called T and B lymphocytes and voila! Patients receiving the vaccine develop the immunity to COVID-19.

Booster Dose

Both vaccines require a “priming dose” and “booster shot,” however the interval for the Pfizer doses is only 21 days with 30 micrograms per dose, while the interval between the Moderna doses is 28 days with 100 micrograms per dose — almost three times the Pfizer vaccine’s amount; ultimately a minor difference.

Storage

Demanding more maintenance, the Pfizer vaccine must be stored at -94ºF and shipped in containers insulated with dry ice. Its minimum purchase order is 975 doses, which may be too much for regions lacking large hospitals. The Moderna vaccine has a more manageable purchase order at 100 doses and only needs to be stored at -40ºF.

New Hope

Although the availability of multiple vaccines may generate confusion, the options are both highly effective and represent an engineering feat in vaccine development.  As the human population recoils from the devastation of COVID-19, we look to a new year with hopes of returning to normal.  In the meantime, the CDC recommends continuing social distancing and  mask usage as before. The possibility of leaving the mask at home may not be far ahead.

Tampa Cardiac Specialist’s Doctor Continues to Blaze Trails for Afib Treatment

CLEARWATER, Fla. (November 17, 2020) – Patients with atrial fibrillation (Afib) turn to the Heart Institute at St. Joseph’s Hospital knowing they will receive some of the most advanced cardiovascular care available in Florida. Likewise, physicians across the country are tuned in to the cutting-edge work underway in this innovative program.

A recent article by St. Joseph’s Hospital’s Heart Institute physicians Kevin Makati, M.D., and Andrew Sherman, M.D., along with colleagues at a Boston hospital, was published by a journal of the American Heart Association, the Journal of the American College of Cardiology, the National Library of Medicine National Center for Biotechnology Information and Cardiology Today. The article highlights the use of “CryoConvergent” hybrid ablation for the treatment of atrial fibrillation (Afib), showing once again how this team continually looks for new opportunities to provide extraordinary patient care.

St. Joseph’s Hospital was the first hospital in the country to perform a cryoablation in 2011, a day after the procedure received FDA approval. Cryoablation is the process of destroying heart tissue using extreme cold. During cryoballoon ablation, a cryoballoon catheter is inserted into the heart, inflated and filled with an extremely cold substance. The extreme cold scars and damages the tissue, preventing it from sending the electrical current that causes Afib.

A year later, the hospital became the only hospital in Hillsborough County to offer Convergent. Convergent is a hybrid, minimally invasive cardiac operation that combines the expertise of electrophysiologists (heart rhythm specialists) and cardiovascular surgeons in a single procedure to treat Afib.

In 2014, the hospital opened its new Heart Institute that included a hybrid suite, making it easier to accommodate Convergent procedures. Thanks to the innovative design, Drs. Sherman and Makati have been teaching visiting physicians and hospitals at reputable programs including the Cleveland Clinic, Mayo Clinic and UCLA as examples. The physicians performed the procedure televised live in front of an international audience this past January at the AF Symposium in Washington DC.

Drs. Makati and Sherman report in the pubications, that findings show that the CryoConvergent procedure may signicantly reduce risk for recurrent Afib and Afib burden in patients with persistent Afib or long-standing persistent Afib. “We’re always looking for advancements that will help our patients feel better and get back to living their best lives,” Dr. Makati said.

AFib is the most common form of heart arrhythmia. It causes the heart to beat too fast, too slow or with an irregular rhythm, increasing the risk of stroke. The Centers for Disease Control and Prevention estimates that 12.1 million people in the United States will have AFib in 2030.

Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation

For decades, patients with early stage atrial fibrillation, termed paroxysmal atrial fibrillation, were required to fail specialized medications to meet eligibility for an afib ablation. The STOP AF First trial showed that a first-line strategy of cryoballoon ablation was superior to antiarrhythmic drug therapy. The trial was led by Dr. Oussama Wazni at the Cleveland Clinic Hospital. Dr. Makati was among the co-authors of the research trial now published in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2029554).

Patients in the trial were randomized to either antiarrhythmic drugs (medications designed to suppress abnormalities involving the heart’s electrical system) or to cryoballoon ablation. Antiarrhythmic drugs are powerful medications with the ability to suppress atrial fibrillation. Unfortunately, their effectiveness ranges from 0-70%. Antiarrhythmic medications have known side effects; in some instances with FDA warnings highlighting the potential for dangerous electrical disturbances and the the possibility of increasing the likelihood of sudden cardiac death.

The study included over two hundred patients with newly diagnosed paroxysmal atrial fibrillation. Roughly half were assigned to the ablation arm, and the remainder assigned to take medications. At the end of 12 months, 75% of the cryoballoon ablation group remained in normal rhythm compared with only 45% of the drug therapy group.

The trial was also notable for the exceptionally low rate of procedural complications. In the past, afib ablation was always considered second line treatment as the procedure was felt to be effective, but with risk. This study confirms that afib ablation can be performed safely with a high degree of success, and now more effective when compared to the current standard of care using only medications.

In summary, among patients with paroxysmal atrial fibrillation, a first-line cryoballoon ablation strategy was superior to antiarrhythmic drug therapy. The strategy appeared to be safe with very few adverse events. The trial is a landmark study which will no doubt shape the practice of electrophysiology.

Hybrid ablation procedure may lower AF recurrence, burden

“Cryoconvergent” hybrid ablation for atrial fibrillation may significantly reduce risk for recurrent AF and AF burden in patients with persistent AF or long-standing persistent AF, researchers reported.

“The hybrid convergent procedure combines minimally invasive epicardial radiofrequency (RF) ablation of the left atrial posterior wall and pulmonary vein (PV) antrum with endocardial PV isolation, and has shown favorable results in achieving sinus rhythm with and without anti-arrhythmic drugs, including in long-standing persistent AF and with longer follow-up,” Kevin Makati, MD, FACC, FHRS, of the electrophysiology lab at St. Joseph’s Hospital of the BayCare Health System in Tampa, Florida, and colleagues wrote. “Most convergent studies used RF as the endocardial and epicardial energy; one previous report investigated endocardial cryothermy. We report safety and efficacy of the convergent procedure using endocardial cryothermy.”

For this retrospective analysis of the TRAC-AF registry, published in Circulation: Arrhythmia and Electrophysiology, researchers included 226 patients who underwent hybrid ablation procedures (mean age, 65 years; 70% men). The primary safety outcome was overall rate of periprocedural complication and the primary effectiveness outcome was freedom from AF or atrial flutter. Individuals underwent convergent procedures with endocardial cryothermy PV isolation (Arctic Front Advance, Medtronic) from November 2011 to May 2018. Recurrence was defined as incidence of more than 30 seconds of AF, atrial flutter or atrial tachycardia on continuous loop monitoring, device interrogation and/or in-office ECG.

Recurrence of AF
Of this cohort, 201 had available 3-, 6-, 12- and 24-month follow-up data.

Overall, 6% of patients experienced periprocedural complications, which included three cases of bleeding and transient/acute renal failure, one pericardial effusion, two phrenic nerve injuries, two vascular complications and one volume overload requiring intubation.

Researchers observed that 75% of patients who were taking previously ineffective anti-arrhythmic drugs were free from AF, atrial flutter and atrial tachycardia after cryoconvergent hybrid ablation.

At the last follow-up, 77% of patients were no longer taking anti-arrhythmic drugs and 69% were free from AF, atrial flutter and atrial tachycardia. Fifty-five percent of the overall cohort was free from arrhythmia and off any anti-arrhythmic drugs.

Moreover, 85% of patients with persistent AF (mean follow-up, 14.7 months) and 70% with long-standing persistent AF (mean follow-up, 16.8 months) were free from AF, atrial flutter and atrial tachycardia.

AF burden reduction
Implantable loop recorders or existing pacemakers were used for continuous loop monitoring of AF burden in 53% of patients, and the remainder had ECGs.

Investigators observed reductions in AF burden within 3 to 12 months of cryoconvergent hybrid ablation for patients with all AF (98.9% reduction), persistent AF (99.3% reduction) and long-standing persistent AF (98.5% reduction). At 12 to 24 months, burden reduction was 91.5% for all AF, 89.3% for persistent AF and 92.5% for long-standing persistent AF.

“Results indicate the ‘CryoConvergent’ procedure provides a promising solution for persistent AF and long-standing persistent AF treatment, evidenced by relatively low AF recurrence rates and marked AF burden reduction after treatment even in long-standing persistent AF.”

Source:Scott Buzby, https://www.healio.com/news/cardiology/20201013/hybrid-ablation-procedure-may-lower-af-recurrence-burden

Drs. Makati and Pastore Named to Tampa Magazines’ 2020 Top Doctors List

July 21, 2020 — Drs. Makati and Pastore were voted by their peers to Tampa Magazines’ 2020 Top Doctors list in the specialty of Electrophysiology and Cardiology.

In May, Tampa Magazines sent surveys to more than 9,000 physicians practicing in Hillsborough, Pinellas and Pasco counties asking them to nominate the peers they believe stand out from the rest. Tampa Bay physicians chose 273 of their peers from 67 practice areas as this year’s Top Doctors.

“Our annual Top Doctors edition has become so popular that we expanded it to include all four of our publications —TAMPA Magazine, South Tampa Magazine, TAMPA Downtown Magazine and TAMPA Digest Magazine for a total circulation of 80,000,” says Shawna Wiggs, group publisher of Tampa Magazines. “You never know when you may find yourself in need of a new physician. This list is a valuable resource that readers consult all year long when they find themselves in need of medical guidance and treatment.”

The 2020 Top Doctors list is now available in the August/September 2020 edition of TAMPA Magazine and will be available in the September/October 2020 edition of South Tampa Magazine, Tampa Downtown Magazine and TAMPA Digest Magazine.

About Tampa Magazines

Tampa Magazines is the parent company of TAMPA Magazine, TAMPA Downtown Magazine, South Tampa Magazine and TAMPA Digest Magazine. The Tampa Magazines team has been telling the city’s story since 2003, highlighting the best that Tampa has to offer in arts and culture, food and drink, home and garden, business, history and personalities. Keep up with the latest on social media @tampamagazine, @southtampamagazine and @tampadowntown and online at tampamagazines.com.

Cardiology and Independence Day

July 4th, 1776 — will forever be remembered as the creation of an everlasting blueprint of the free world. It was on this day that the Declaration of Independence was unanimously adopted by Congress, resulting in the beginning of the American Revolutionary War and ending with the country of America as we know it. And while the 18th century was a historic moment for America and its grueling battle for freedom, unknowingly, it was a pivotal time in the field of cardiology, bringing forth significant medical discoveries that would forever change the way the heart was understood.

More than a century before America was declared independent, the pioneering work of physician William Harvey was published, detailing the anatomy of the heart and circulation in 1628.  Stephen Hales successfully demonstrated the relationship between blood in the arteries and blood pressure.  The mid-18th century would usher in more clues as to how the heart worked.  Surprisingly,  early doctors cared less about the field of cardiology and more about understanding why chest pain or angina pectoris occurred (from the Greek agkhon which means “strangling”). The discipline of cardiovascular medicine was born and with it more questions than answers.

As American colonists dumped tea into the Boston Harbor, an important paper was in the making. Physician William Heberden published an influential study on chest pain in the 1770’s. Boston’s own, John Collins Warren, was a surgeon who co-founded the influential New England Journal of Medicine, authoring a paper on chest pain.  Shortly after, John Wall made a connection between chest pain and clogged arteries, creating a revolution that would lead to clot busters and eventually the modern stents we use now to open them. The 18th century created the necessary groundwork for inventions like the stethoscope, pacemakers, and ultrasounds.

So as we enjoy Independence day and our holiday weekend and give thanks to our nation’s founding fathers, we remember the early pioneers across the world who at a tumultuous time in American history, created the underpinnings of cardiovascular medicine.

Novel Coronavirus COVID 19 and Heart Disease

What is known…
The novel COVID-19 virus or SARS-CoV2, is the 7th known virus within the coronavirus family. Severe Acute Respiratory Syndromes (SARS) have occurred in the past as a result of other coronarviruses, however the unique characteristics of COVID-19 have made it particularly notorious. One feature of COVID-19 that has gained controversy is where it originated from. Coronaviruses have been found in animal species including the pangolin and the bat. COVID-19 is 96.2% identical to bat coronarviruses supporting the theory that the initial infection was contracted from these animal species however this continues to be debated. The virus uses a protein found abundantly within the lungs entering the cells in a similar fashion to HIV. A single patient infected with COVID-19 is estimated to spread on average to 2-3 individuals. Compare this with the infectivity of Influenza which falls between 1.4-1.6. The rate of death after a patient contracts COVID-19 is significantly higher than Influenza however less than other viral syndromes. Unfortunately, a virus which does not kill its host immediately is in fact a greater threat to the public as this enables the virus to spread more efficiently. In the case of COVID-19, patients may not immediately have symptoms which enhances the viruses ability to spread undetected. In fact, the symptoms of COVID-19 infection are common to many respiratory infections and include fever, shortness of breath, fatigue, and diarrhea.

What was once thought to be a health issue endemic to Wuhan, Hubei, China, is now a pandemic; or a disease process affecting the entire world.  Originally identified in December of 2019 as an isolated case is now at the time of this writing at 381,598 confirmed cases in 168 countries/regions and 16,559 deaths worldwide. For current numbers, please visit our COVID-19 resource page to find informative resources here (https://www.tampacardiac.com/covid19).

The issue at heart…

Of the original cases identified, patients at greatest risk for serious complications even death included age, and coexisting disease such as cancer, hypertension, lung disease, diabetes, and of greatest risk, cardiovascular disease.  In fact, patients with cardiovascular disease in the original case studies had a risk of dying as high as 10.5%.  The risk of death and complications of the disease rose from 8% for patients aged 70-79 to 14.8% in patients over the age of 80.  While many theories abound, the high risk of complications and death in elderly patients and patients with cardiovascular disease remain unknown.  Although the risk in the elderly is attributed to weakened immune systems, the cause of injury in heart disease patients appear to be related to an increased inflammatory state caused by the infection leading to arrhythmias or electrical heart disturbances, coronary syndromes such as heart attacks, and myocardial depression leading to heart failure. Observations made while investigating other similar viral illnesses such as the Middle East Respiratory Syndrome and Influenza, help us understand why patients with cardiovascular disease might experience more complications with COVID-19 than other infected patients. Myocarditis, or infection of the heart, can occur with many viral illnesses. The presence of infection involving the heart has been documented on MRI studies and this has been thought of as a principal cause of cardiac arrest, heart failure and electrical disturbances or arrhythmia. Electrical disturbances in particular have been noted in as many as 16.7% of patients hospitalized in China.

Treatment for COVID19…

At the current time, there are several strategies being investigated: either antiretroviral therapies used to treat other viral infections such as Ebola or HIV, an antimalarial drug called Hydrochlorquine, steroids, a drug used for rheumatoid arthritis, antibodies extracted from a previously infected patient, or a vaccination; a gold standard treatment is not known as of yet.  Until such a day, the advice by officials is to observe isolation or social distancing, appropriate hygiene to avoid contracting the virus, use of telehealth where possible to avoid the waiting room, and finally, vaccination against other common infectious diseases such as bacterial pneumonia and Influenza.

Other controversies…

There have been many controversial statements made about anti inflammatory agents and classes of blood pressure pills such as ACE inhibitors (lisinopril for example) and ARBs (losartan for example).  The ACC does not advise discontinuing blood pressure pills to avoid increasing the damage caused by COVID19 and in fact cautions patients that discontinuation of these drugs may in itself cause complications.  With regards to anti inflammatory agents or NSAIDS, authorities do not feel these agents are of significant harm in patients who are infected with the virus. Guidelines change daily.

A disease in evolution…

It is important to note that much of the recommendations for how to manage COVID19 are being borrowed by the behavior and response of other viral infections such as Influenza and/or observations made in China.   The recommendations change weekly if not daily.  For that reason, authorities such as the CDC should be the first source of information as their sites are updated frequently.  The CDC website can be found here: (https://www.cdc.gov/coronavirus/2019-ncov/index.html).