New Cardiology Board Rejected by ABMS: What It Means for the Future of Cardiovascular Certification

Hopes for a new cardiology certification board were dashed when the American Board of Medical Specialties (ABMS) denied the American Board of Cardiovascular Medicine (ABCVM) application. This decision has sparked disappointment and frustration within the cardiology community, as many experts believe cardiovascular medicine has evolved into a distinct specialty that warrants its own certification process.

Why Was ABCVM Proposed?

The idea for an independent certification body for cardiologists emerged from long-standing dissatisfaction with the American Board of Internal Medicine (ABIM). Critics argue that ABIM’s maintenance of certification (MOC) process is expensive, time-consuming, and fails to provide meaningful benefits for specialists. The move to create ABCVM was announced in September 2023, with support from major cardiovascular societies, including:

• The American College of Cardiology (ACC)
• The Heart Rhythm Society
• The Heart Failure Society of America
• The Society for Cardiovascular Angiography and Interventions (SCAI)
• The American Heart Association (AHA) (which joined later in October 2023)

ABMS Decision: A Step Backward?

Leaders of the proposed ABCVM argue that cardiovascular medicine is now separate from internal medicine, requiring a distinct set of knowledge, skills, and competencies. They also emphasize that traditional certification models do not reflect how modern clinicians learn and demonstrate proficiency throughout their careers.

Many have expressed disappointment with ABCVM’s application rejection, believing that ABMS has missed an opportunity to adopt a more specialized and modern certification framework.

What’s Next? The Fight Continues

Despite the setback, ABCVM supporters are not giving up. The ABCVM board of directors is now evaluating potential next steps, and organizations like SCAI have expressed continued commitment to reforming the certification process.

SCAI officials stated that ABMS had a chance to support an innovative and evidence-based certification model that aligns with how cardiovascular specialists train, practice, and maintain their skills. Instead, the current system remains outdated and disconnected from the realities of modern medicine.

ABMS, on the other hand, has remained silent on the specifics of the rejection, only referring to its publicly available policies on new board applications.

Take-Home Key Points

• The American Board of Cardiovascular Medicine (ABCVM) was denied recognition by ABMS.
• The certification process for cardiologists remains under ABIM despite concerns over its cost and effectiveness.
• The rejection ignores the evolution of cardiovascular medicine as a separate specialty.
• Supporters of ABCVM argue that a new board would better reflect modern learning and skill demonstration.
• Despite the rejection, efforts to change the certification system continue, with strong backing from major cardiovascular societies.

This decision marks a crucial moment for cardiologists, who continue to advocate for a more effective, fair, and relevant certification process that genuinely serves their profession and their patients.

New ACC/AHA Guidelines for Acute Coronary Syndrome (ACS) Management: Key Updates for Clinicians

The American College of Cardiology (ACC) and the American Heart Association (AHA) have released a comprehensive guideline on the management of acute coronary syndrome (ACS), combining recommendations for ST-elevation myocardial infarction (STEMI) and non-ST-elevation ACS (NSTE-ACS). This update integrates recent evidence and reflects a contemporary approach to coronary revascularization, intracoronary imaging, mechanical circulatory support, and secondary prevention.

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Key Updates in ACS Management

1. Complete Revascularization

• Complete revascularization is now a Class 1 recommendation for both STEMI and NSTE-ACS.
• A single procedure approach is preferred over a staged approach (2021 Coronary Revascularization Guidelines).

2. Intracoronary Imaging

• Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) is now a Class 1 recommendation during percutaneous coronary intervention (PCI) in patients with left main or complex lesions.
• This update follows RCT data demonstrating improved stent-related and clinical outcomes (OCTIVUS Meta-Analysis).

3. Mechanical Circulatory Support (Impella)

• The Impella CP device, a microaxial intravascular flow pump, receives a Class 2a recommendation for selected patients with STEMI and severe or refractory cardiogenic shock.
• This follows the DanGer Shock trial, which showed survival benefits but also highlighted risks of peripheral arterial complications (DanGer Shock Trial).

4. Blood Transfusion in ACS

• Liberal red blood cell transfusion to maintain hemoglobin ≥10 g/dL in patients with acute MI and anemia receives a Class 2b recommendation.
• This stems from findings in the MINT trial, which suggested potential reductions in cardiac death (MINT Trial).

5. Dual Antiplatelet Therapy (DAPT) and Bleeding Risk Reduction

• DAPT (aspirin + P2Y12 inhibitor) for at least 12 months remains a Class 1 recommendation for patients at low bleeding risk.
• Ticagrelor monotherapy after 1 month is an option for patients with high bleeding risk.
• Proton pump inhibitors (PPIs) should be used in patients at risk of gastrointestinal bleeding.

6. Lipid Management and Secondary Prevention

• Lipid panel measurement is recommended 4 to 8 weeks after starting or adjusting lipid-lowering therapy.
• If LDL remains ≥70 mg/dL despite statin therapy, adding a nonstatin agent (ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid) is a Class 1 recommendation.
• If LDL is between 55-69 mg/dL, adding a nonstatin is reasonable (Class 2a).
• Cardiac rehabilitation is strongly recommended before discharge (Class 1), and home-based programs are a reasonable alternative (Class 2a).

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What Clinicians Should Know

• Class 1 recommendations should be widely implemented as they have strong evidence of benefit.
• Class 2a recommendations (e.g., Impella) indicate that procedures may be beneficial but require careful patient selection.
• Class 2b recommendations (e.g., liberal transfusion strategies) suggest potential benefit but require further validation.
• Class 3 recommendations (Do Not Do) include:
  • Manual aspiration thrombectomy in primary PCI for STEMI.
  • Routine PCI of non-infarct-related arteries in ACS patients with cardiogenic shock.
  • Routine use of glycoprotein IIb/IIIa inhibitors due to increased bleeding risk.

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Take-Home Points

1. Complete revascularization in ACS patients is now a Class 1 recommendation.
2. IVUS and OCT should be used during PCI for left main and complex lesions.
3. Impella may improve survival in selected cardiogenic shock patients, but risks must be considered.
4. DAPT remains critical, but strategies to minimize bleeding risk should be individualized.
5. Aggressive LDL lowering is essential for secondary prevention.
6. Cardiac rehabilitation is a must, and home-based programs can be considered.

The implementation of these evidence-based recommendations will be key to improving patient outcomes in ACS management.

For further details, read the full guideline publication in the Journal of the American College of Cardiology and Circulation.

Advancements in Atrial Fibrillation Management: Key Clinical Trials and Their Implications

Atrial fibrillation (AF) remains a prevalent cardiac arrhythmia, posing significant challenges in clinical practice. Recent landmark trials have provided insights that are reshaping AF management strategies. Below is a synthesis of pivotal studies, each accompanied by direct hyperlinks for detailed review.

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1. Rhythm Control vs. Rate Control: Revisiting Treatment Paradigms

Historically, rate control was favored in AF management. However, the EAST-AFNET 4 Trial demonstrated that early rhythm control significantly reduces cardiovascular (CV) events, including stroke, heart failure (HF) hospitalizations, and even mortality, compared to usual care.

✅ Key Takeaway: Early rhythm control improves long-term outcomes in AF patients.

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2. Catheter Ablation vs. Antiarrhythmic Drugs (AADs): Which Is Superior?

The efficacy of catheter ablation as a first-line therapy has been evaluated in multiple trials:

• EARLY-AF Trial – Found that cryoablation was more effective than AADs in maintaining sinus rhythm among patients with paroxysmal AF.
• STOP AF First Trial – Confirmed that cryoablation was superior to AADs in preventing atrial arrhythmia recurrence.

✅ Key Takeaway: Catheter ablation, particularly cryoablation, is more effective than AADs in maintaining sinus rhythm.

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3. Preventing AF Progression: The Role of Early Intervention

Preventing the progression of AF is crucial:

• ATTEST Trial – Demonstrated that early radiofrequency ablation (RFA) reduced progression from paroxysmal AF (PAF) to persistent AF (PeAF) compared to AAD therapy.

✅ Key Takeaway: Early ablation can prevent AF progression, reinforcing the need for timely intervention.

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4. Comprehensive Ablation Strategies for Persistent AF

For persistent AF (PeAF), strategies beyond pulmonary vein isolation (PVI) have been explored:

• PRECEPT Trial – Found that PVI alone was not enough and that additional posterior wall and roof/floor lesions significantly improved outcomes.

✅ Key Takeaway: Persistent AF requires comprehensive ablation beyond PVI.

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5. Hybrid Approaches in Long-Standing Persistent AF

Combining surgical and catheter-based interventions has shown promising results:

• CONVERGE Trial – Showed that the hybrid convergent procedure (surgical epicardial and endocardial ablation) was superior in persistent and long-standing persistent AF (LSPeAF).

✅ Key Takeaway: Hybrid ablation can be highly effective in complex AF cases.

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6. Cognitive Outcomes: Impact of Anticoagulation and Ablation

AF has been linked to cognitive decline, but certain interventions may mitigate this risk:

• Friberg et al. (2017) – Found that oral anticoagulation (OAC) was associated with a 29% lower risk of dementia.
• Al-Kaisey et al. (2022) – Indicated that catheter ablation had positive effects on cognitive function.

✅ Key Takeaway: Anticoagulation and ablation may protect against cognitive decline.

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7. Mortality Benefits of Catheter Ablation

Does catheter ablation improve survival?

• CABANA Trial – Found that ablation might reduce mortality and cardiovascular hospitalizations in AF patients.

✅ Key Takeaway: Ablation may have mortality benefits, especially in high-risk patients.

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8. Catheter Ablation for AF in Heart Failure Patients

Several studies have assessed the role of ablation in heart failure (HF):

• CAMERA MRI Trial – Found that ablation led to significant improvements in left ventricular ejection fraction (LVEF).
• CASTLE-AF Trial – Demonstrated that catheter ablation reduced mortality and heart failure hospitalizations in patients with reduced ejection fraction (HFrEF).

✅ Key Takeaway: Ablation significantly improves LVEF and reduces heart failure events in AF patients.

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9. Innovations in Ablation: Pulsed Field Ablation (PFA)

New non-thermal ablation techniques are emerging:

• ADVENT Trial – Evaluated Pulsed Field Ablation (PFA) and found it to be as effective as radiofrequency (RFA) or cryoablation but with shorter procedure times and improved safety.

✅ Key Takeaway: Pulsed Field Ablation (PFA) is a promising advancement in AF ablation.

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Conclusion: Integrating Evidence into Clinical Practice

The landscape of AF management is rapidly evolving, guided by robust clinical evidence. Early intervention, catheter ablation, and novel technologies are improving patient outcomes and reducing complications.

Key Takeaways for Healthcare Professionals:

✔ Early rhythm control improves long-term outcomes.
✔ Catheter ablation is superior to AADs in maintaining sinus rhythm.
✔ Early ablation may prevent AF progression.
✔ Persistent AF requires additional ablation beyond PVI.
✔ Hybrid ablation is effective in long-standing persistent AF.
✔ Anticoagulation and ablation may protect against dementia.
✔ Ablation may reduce mortality, especially in heart failure patients.
✔ Pulsed Field Ablation (PFA) is a safer, faster alternative.

Can’t Exercise for a Cardiac Stress Test? That’s a Bad Sign

 The Connection Between Exercise and Mortality Risk

New research highlights that the inability to exercise during a cardiac stress test is a strong predictor of long-term mortality. Patients who require a pharmacologic stress test instead of a treadmill test face significantly higher risks of death over time.

A study published in Mayo Clinic Proceedings analyzed 11,256 patients over a mean follow-up period of 6.7 years. The findings revealed that individuals unable to exercise had a mortality rate of 19.2%, compared to only 2.6% among those who could perform a treadmill test. This underscores the protective effects of physical activity and the high-risk nature of those who cannot exercise.

Key Findings from the Study

• Exercise vs. Pharmacologic Stress Testing: Patients requiring pharmacologic stress testing had more CAD risk factors, higher comorbidities, and an increased likelihood of myocardial ischemia.

• Mortality Trends: Among those undergoing pharmacologic testing, the annual mortality rate ranged from 1.4% to 7.7%, depending on risk factor burden. In contrast, for those able to exercise, the mortality risk was below 1%, even with multiple comorbidities.

• Risk Factors: After adjusting for risks, the strongest mortality predictors were age (HR 1.27 per 5 years) and pharmacologic testing (HR 4.61 without a walk, HR 2.35 with a walk).

The "Magic Pill" of Exercise

The lead investigator emphasizes the broad physiological benefits of exercise, stating:

"We know that exercise is that magic pill. It improves insulin resistance, enhances endothelial function, reduces atherosclerosis risk, strengthens muscle conditioning, and lowers frailty risk."

The Need for Better Stress Test Reporting

Currently, stress test reports focus primarily on ischemia, overlooking the predictive value of exercise capacity. A more holistic approach, integrating data on exercise ability and overall clinical risk assessment, is needed.

A strong relationship between a patient’s inability to exercise and a higher mortality risk was noted. Long-term impact of this finding is striking.

Optimizing Stress Testing Strategies

• Consider PET Imaging: PET scans provide greater accuracy in detecting triple-vessel disease, making them preferable for pharmacologic stress testing.

• Assess Coronary Calcium Scores: High calcium scores (>1000) may warrant closer monitoring or cath lab evaluation, even if perfusion appears normal.

• Refine Report Interpretations: Stress test reports should explicitly highlight the higher risk associated with an inability to exercise.

Take-Home Points

• The inability to exercise during a stress test is a major red flag for long-term mortality.

• Patients requiring pharmacologic stress testing have higher mortality risks, even after adjusting for CAD risk factors.

• Exercise acts as a "magic pill," enhancing multiple physiological systems and reducing cardiovascular risk.

• Stress test reports should emphasize the predictive value of exercise ability, not just ischemia detection.

• PET imaging and coronary calcium scoring should be utilized for better risk stratification in pharmacologic stress test patients.

Final Thought

This study reinforces a fundamental truth in cardiology: if you can exercise, do it. Your ability to move is not just about fitness—it’s a powerful indicator of your overall health and longevity. If a patient cannot exercise for a cardiac stress test, clinicians should view it as a serious warning sign and take proactive steps to optimize their care.

Why Medicaid is Under Threat: Key Issues and Potential Cuts

Medicaid is a crucial component of the U.S. social safety net, providing health insurance to low-income individuals. However, it has become a major target for budget cuts, especially by Republican lawmakers who seek to offset tax cuts.

What is Medicaid?

• Medicaid provides health insurance to over 72 million Americans.

• Covers children, senior citizens, individuals with disabilities, parents, and adults without dependents.

• 7.2 million children are enrolled through the Children’s Health Insurance Program (CHIP).

• It supports two in five children, 40% of all births, 60% of nursing home residents, and 30% of non-elderly adults with mental illness.

• Medicaid also funds substance abuse treatment.

Variations in Medicaid Coverage by State

• Medicaid benefits and eligibility vary significantly between states.

• Some states provide expanded benefits such as prescription drugs, vision, and dental services.

• 40 states and Washington D.C. have expanded Medicaid under the Affordable Care Act (ACA), covering individuals earning up to 138% of the federal poverty level.

• Income eligibility in non-expansion states varies widely, with some states offering as little as 15% of the federal poverty level.

How Medicaid is Funded

• Medicaid is jointly funded by the federal government and individual states.

• The federal government covers 90% of costs for Medicaid expansion enrollees.

• Traditional Medicaid funding varies by state, with a minimum 50% match from the federal government.

• Some states require nominal copays for services.

Why Medicaid is a Target for Budget Cuts

• Medicaid spending in 2023 totaled $880 billion, with the federal government covering 69%.

• Accounts for nearly one-fifth of U.S. healthcare spending.

• Republicans aim to shrink Medicaid, arguing that it is prone to waste, fraud, and abuse.

• There is a strong push for work requirements for able-bodied adults receiving Medicaid benefits.

Potential Medicaid Cuts and Their Impact

• House Republicans propose deep cuts, with options that could trim trillions from the program.

• Suggested changes include:

  • Work requirements, potentially affecting 36 million people.

  • Reducing federal funding for Medicaid expansion, which could force states to withdraw, leading to up to 20 million people losing coverage.

  • Per capita caps on federal funding, potentially cutting Medicaid by $532 billion to $1 trillion over a decade and affecting 15 million beneficiaries.

Concerns About Medicaid Waste and Fraud

• The improper payment rate for Medicaid was 5.1% ($31 billion) in 2024, mostly due to insufficient documentation.

• Government Accountability Office (GAO) reports Medicaid is at risk of mismanagement, waste, and fraud.

• In 2023, Medicaid accounted for 21% of all federal improper payments.

Public Opinion on Medicaid

• More than 75% of Americans view Medicaid favorably.

• Support spans across political lines: 63% of Republicans, 81% of independents, and 87% of Democrats favor the program.

• Past Republican attempts to cut Medicaid, particularly in 2017, contributed to electoral losses in 2018.

Conclusion

Medicaid is a lifeline for millions of Americans, covering essential healthcare needs for vulnerable populations. However, it remains a contentious issue in budget discussions, with Republican lawmakers advocating for deep cuts to offset tax reductions. While concerns over waste and fraud exist, Medicaid remains widely popular among Americans. Any proposed reductions could have significant consequences, potentially stripping coverage from millions and reshaping the future of healthcare for low-income individuals in the U.S.

Key Takeaways:

• Medicaid supports over 72 million Americans, including children, seniors, and individuals with disabilities.

• Funding varies by state, with federal and state governments sharing costs.

• Medicaid spending totaled $880 billion in 2023, accounting for a large portion of healthcare expenditures.

• Proposed cuts could affect up to 36 million individuals through work requirements and funding reductions.

• Medicaid remains widely popular across party lines, but its future is uncertain due to ongoing budget debates.

Safe and Effective Diagnosis of Microvascular Dysfunction in ANOCA: Insights from the NL-CFT Study

 1. Safe Diagnosis of ANOCA with Invasive Testing

• Invasive coronary functional testing can safely identify the cause of angina in patients with nonobstructive coronary artery disease (ANOCA).
• The testing was performed across 15 hospitals in the Netherlands, including both tertiary and nontertiary centers.
• The Netherlands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT) showed a high diagnostic yield and low complication rates.

2. Guidelines and Recommendations

• According to the 2024 European Society of Cardiology (ESC) guidelines, invasive coronary angiography with functional testing is recommended to:
  • Confirm or exclude obstructive coronary disease.
  • Diagnose ANOCA and identify treatable endotypes.
• In the US, invasive testing is considered reasonable for diagnosing persistent chest pain without coronary obstruction.

3. High Prevalence of Microvascular Dysfunction

• Around 50% of patients undergoing coronary angiography for angina show no coronary obstruction.
• Many patients, especially women, experience significant symptoms even without obstruction, affecting their physical function, mental health, and quality of life.
• Physicians are encouraged to investigate microvascular dysfunction instead of stopping at angiography.

4. Study Findings (NL-CFT Data)

• The study involved 1,207 patients (mean age: 60 years; 81% female).
• Testing included:
  • Intracoronary acetylcholine to provoke coronary spasm.
  • Measurements of coronary flow reserve and microvascular resistance using intravenous adenosine.
• Results:
  • 78% had abnormal test results:
    • 9% had coronary microvascular dysfunction (CMD).
    • 31% had isolated epicardial spasm.
    • 12% had epicardial spasm with CMD.
    • 17% had isolated microvascular spasm.
    • 9% had both microvascular spasm and CMD.

5. Safety and Complications

• The major complication rate was 0.9%, including:
  • Coronary dissections.
  • Ventricular tachycardia or ventricular fibrillation.
  • Hemodynamic instability.
• The complication rate was similar between tertiary and nontertiary centers.
• Atrial fibrillation requiring conversion occurred in 0.8% of patients.

6. Tailored Therapy and Treatment Recommendations

• Identification of specific ANOCA endotypes enables personalized treatment:
  • Calcium channel blockers for isolated vasospasm (Class I, Level A).
  • Nitrates to prevent recurrence (Class II, Level B).
  • Beta-blockers for microvascular angina (Class IIa, Level B).
  • Combination therapies for overlapping conditions (Class IIb, Level B).
• CorMicA study demonstrated improved symptoms and quality of life with tailored treatments.

7. Recommendations for Testing Centers

• Invasive functional testing should be integrated into centers performing angiography.
• No special expertise is required beyond standard angiographic procedures.

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Take-Home Points:

• Invasive coronary functional testing is safe and provides a high diagnostic yield for patients with ANOCA.
• Many patients with angina have no obstructive coronary disease but may still suffer from microvascular dysfunction.
• Diagnosis through invasive testing can guide tailored treatments, improving both symptoms and quality of life.
• Complication rates are low, making this testing approach feasible in both experienced and less-experienced centers.
• Guidelines recommend combining therapies for patients with overlapping vasomotor dysfunctions.

The Olpasiran Paradox: Lowering Lp(a) Without Reducing Inflammation

 In the ever-evolving field of cardiology, lipoprotein(a) [Lp(a)] has emerged as a crucial risk factor for atherosclerotic cardiovascular disease (ASCVD). Many believed that lowering Lp(a) would also reduce inflammation, given its suspected role in triggering inflammatory pathways. However, recent findings from the OCEAN(a)-DOSE trial challenge this widely held assumption.

Breaking the Link: Lp(a) and Inflammation

The trial investigated the effects of olpasiran, a novel small interfering RNA (siRNA) therapy. The results confirmed that olpasiran significantly lowers Lp(a) levels, with reductions ranging from 51.6% to 92.3% at 36 weeks. Furthermore, oxidized phospholipids (OxPL), which are thought to contribute to ASCVD, also decreased in parallel with Lp(a). Despite these promising findings, a surprising revelation emerged: there was no corresponding drop in key inflammatory markers such as high-sensitivity interleukin-6 (hs-IL-6) and C-reactive protein (hs-CRP).

One investigator summarized the unexpected nature of these results: “There was a concept that has been promulgated that this pathway was linear: high Lp(a), high oxidized phospholipids, high levels of inflammation, and more cardiovascular events. If you read the literature, everybody’s convinced that this is the pathway, and we’re demonstrating that this is not the pathway.”

What Does This Mean for Cardiovascular Risk?

For years, the prevailing hypothesis suggested that reducing Lp(a) would automatically mitigate inflammation, thereby reducing cardiovascular risk. This study suggests otherwise, raising important questions:

• If Lp(a) isn’t directly driving inflammation, what mechanism makes it so dangerous?

• Are circulating inflammatory markers like hs-IL-6 and hs-CRP inadequate for assessing vascular inflammation?

• Could other, yet-to-be-identified inflammatory proteins be responsible for Lp(a)-related cardiovascular events?

One expert calls these findings “head-scratching,” but emphasizes that they do not change the well-established role of Lp(a) in increasing cardiovascular risk. “In the end, all that matters is outcomes. We just need the clinical trials.”

The Road Ahead: OCEAN(a) Cardiovascular Outcomes Trial

The ongoing OCEAN(a) cardiovascular outcomes trial aims to provide definitive answers. It will assess whether lowering Lp(a) with olpasiran translates into fewer cardiovascular events, irrespective of inflammatory marker changes. If successful, olpasiran could become a key therapeutic option for patients with high Lp(a), a population historically lacking targeted treatments.

As cardiologists, we must remain open to new paradigms in cardiovascular disease. The OCEAN(a)-DOSE trial reminds us that even well-established concepts can be challenged, and understanding the true nature of Lp(a) in cardiovascular risk remains a complex puzzle yet to be fully solved.

Stay tuned as we await the results of the OCEAN(a) outcomes trial—because in medicine, outcomes always matter more than theories.

Driving Considerations for Patients with Implantable Cardioverter-Defibrillators (ICDs)

Introduction

The clinical indications for implantable cardioverter-defibrillators (ICDs) have significantly evolved over the past two decades.

Initially used for secondary prophylaxis following resuscitation from ventricular fibrillation (VF) or sustained ventricular tachycardia (VT), ICDs are now also widely recommended for primary prophylaxis in selected high-risk patients without prior cardiac arrest.

While these devices improve survival, they do not eliminate the risk of sudden incapacitation, which poses a concern for driving safety.

Patients with ICDs are comparable to individuals with epilepsy in that they appear fit to drive but may suddenly become impaired due to an arrhythmic episode or ICD shock.

This unpredictability necessitates careful assessment of the risks associated with driving and the implementation of appropriate restrictions to ensure both patient and public safety.

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Understanding the Risks

ICDs treat arrhythmic manifestations but do not eliminate the underlying cardiac disease, leaving patients at risk for syncope due to VT or VF.

Even with early shock therapy from the ICD, sudden cardiac death (SCD) remains a possibility.

Furthermore, the pain and psychological impact of an ICD shock may lead to transient incapacitation.

In any society, driving is a privilege restricted to individuals who do not pose excessive risk to themselves or others, making it crucial to evaluate the risk posed by ICD patients and implement appropriate driving restrictions.

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Risk of Harm (RH) Estimation

In 1992, the Canadian Cardiovascular Society developed a formula to estimate the risk of harm (RH) posed by a driver with cardiac disease:

RH=TD×V×SCI×Ac

where:

• TD = time spent driving,

• V = type of vehicle driven,

• SCI = risk of sudden cardiac incapacitation,

• Ac = probability of an event leading to an accident.

The annual RH threshold considered acceptable for driving is 5 in 100,000.

Given that society already accepts some level of driving risk among the general population, a goal of zero risk is impractical.

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Driving Risk in Patients with ICDs for Secondary Prophylaxis

Patients who receive an ICD for secondary prophylaxis have a high likelihood of arrhythmia recurrence.

Studies indicate that the risk of ICD shocks over five years ranges from 55% to 70%, with the highest incidence occurring in the first year post-implantation.

Syncopal episodes related to ICD discharges are reported in 10-15% of cases.

However, the overall risk of road accidents remains low.

A survey of 452 U.S. physicians found only 30 motor vehicle accidents related to ICD shocks over 12 years.

Furthermore, the fatality rate among ICD patients (7.5/100,000 patient-years) was significantly lower than the general U.S. population fatality rate (18.4/100,000 patient-years).

Given these findings, the American Heart Association/North American Society of Pacing and Electrophysiology (AHA/NASPE) recommends a six-month driving restriction for secondary prophylaxis ICD patients.

In contrast, the European Heart Rhythm Association (EHRA) has updated its guidelines to recommend a three-month restriction.

Despite some recent studies suggesting even shorter or no restrictions, the six-month restriction remains the standard recommendation in the U.S.

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Driving Risk in Patients with ICDs for Primary Prophylaxis

The risk of ICD discharges in primary prophylaxis patients has decreased over time.

Earlier studies reported high discharge rates (50-60% over two years), whereas modern trials report an annual incidence of 7.5%.

Given that an ICD patient drives an average of 8-20 miles per day (approximately 2% of their daily time), the estimated probability of an ICD discharge while driving is 0.15% per year.

The AHA guidelines recommend no private driving restrictions for asymptomatic patients receiving ICDs for primary prevention, except for an initial one-week restriction post-implantation to allow stabilization.

The EHRA similarly recommends four weeks of restriction following ICD implantation.

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Driving Considerations Following an ICD Discharge

An ICD discharge, whether appropriate or inappropriate, necessitates reevaluation of driving safety.

If an ICD therapy is delivered for VT or VF with symptoms of cerebral hypoperfusion, a six-month driving restriction is recommended.

In cases of inappropriate shocks, driving should be restricted until corrective measures (device reprogramming, lead replacement, or medication adjustments) are implemented.

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Driving Restrictions for Commercial Drivers

Federal regulations strictly govern commercial licensing.

Given the high exposure time and vehicle size, commercial drivers with ICDs, whether implanted for primary or secondary prevention, are permanently ineligible to operate commercial vehicles.

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Key Takeaways

• ICD recipients for primary prophylaxis should avoid driving for one week post-implantation.

• ICD recipients for secondary prophylaxis should avoid driving for six months.

• Appropriate ICD discharges for VT or VF require a six-month restriction.

• Commercial driving is permanently restricted for ICD patients.

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Conclusion

Ensuring driving safety for patients with ICDs requires a careful balance between mitigating road risks and maintaining the individual's independence and quality of life.

While ongoing research may refine recommendations further, current guidelines emphasize caution to **safeguard both patients and the public. **

Learn More

Driving Regulations for Patients with Cardiac Implantable Electronic Devices (CIEDs)

 Regulations for pacemakers and implantable cardioverter-defibrillators (ICDs) differ between the United States and Europe to ensure both patient safety and public road safety.

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United States Regulations

Pacemakers

• Patients are advised to refrain from driving for at least one week post-implantation to allow for recovery and device stability.
  📖 Source: American Heart Association (AHA) (acc.org)

ICDs

• Primary Prevention (patients without prior arrhythmic events)

  • A driving restriction of approximately one week is recommended post-implantation.
    📖 Source: Heart Rhythm Society (HRS) (acc.org)

• Secondary Prevention (patients with a history of arrhythmic events)

  • A driving ban of about six months is advised following ICD implantation.
    📖 Source: American Heart Association (AHA) (acc.org)

• After ICD Shock (appropriate or inappropriate)

  • Patients are typically advised to cease driving for six months after receiving a shock.
    📖 Source: Heart Rhythm Society (HRS) (acc.org)

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European Regulations

📖 Source: European Society of Cardiology (ESC), European Heart Rhythm Association (EHRA) (academic.oup.com)

Pacemakers

• Private Drivers: A one-week driving restriction is recommended post-implantation.
  📖 Source: EHRA (academic.oup.com)
• Commercial Drivers: Driving is disqualified until pacemaker integrity is confirmed.
  📖 Source: EHRA (academic.oup.com)

ICDs

• Primary Prevention

  • Private Drivers: A driving ban of one month is recommended post-implantation.
    📖 Source: EHRA (academic.oup.com)
  • Commercial Drivers: Permanent disqualification from driving.
    📖 Source: EHRA (academic.oup.com)

• Secondary Prevention

  • Private Drivers: A driving restriction of three months is advised after implantation.
    📖 Source: EHRA (academic.oup.com)
  • Commercial Drivers: Permanent disqualification from driving.
    📖 Source: EHRA (academic.oup.com)

• After ICD Shock

  • Private Drivers: A three-month driving ban is recommended following an appropriate shock.
    📖 Source: EHRA (academic.oup.com)
  • Commercial Drivers: Permanent disqualification from driving.
    📖 Source: EHRA (academic.oup.com)

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Adherence to Driving Restrictions

• A Danish study found that nearly one-third of ICD patients resumed driving during the restricted period, often due to a lack of awareness of the guidelines.
  📖 Source: European Society of Cardiology (ESC) (escardio.org)

• Education and awareness efforts are crucial to ensure patient compliance with driving regulations.
  📖 Source: European Society of Cardiology (ESC) (escardio.org)

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Conclusion

While there are broad international guidelines for driving restrictions following pacemaker and ICD implantation, regulations vary based on patient history, device type, and national policies. Patients should consult their healthcare provider and local regulatory authorities to ensure they comply with specific driving restrictions in their country.

📖 Main References:

1. American Heart Association (AHA), Heart Rhythm Society (HRS) – ACC.org
2. European Society of Cardiology (ESC), European Heart Rhythm Association (EHRA) – academic.oup.com
3. Driving Compliance Study (ESC) – escardio.org

Driving Safety After ICD Implantation: No Increased Risk, but Caution Advised

New research from Canada suggests that receiving an implantable cardioverter-defibrillator (ICD) within the past six months does not significantly increase the risk of serious motor vehicle accidents. However, due to limitations in statistical power, the possibility of some increased hazard cannot be entirely ruled out.

The study, published in JACC: Clinical Electrophysiology, analyzed population-based health and driving records from British Columbia to assess whether patients who had an ICD implanted within six months were at a higher risk of being involved in or responsible for a crash. While the findings were largely reassuring, researchers emphasize the need for continued monitoring—especially since driving restrictions for ICD recipients have been eased in recent years.

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🚗 Key Take-Home Points

✅ No Significant Increase in Car Crashes: Patients who received an ICD in the past six months were not more likely to be involved in a crash compared to controls.
✅ Crash Responsibility Remains Uncertain: While there was no statistically significant increase in ICD recipients being blamed for accidents, the small sample size leaves room for uncertainty.
✅ Driving Restrictions Vary by Region: Rules in Canada and Europe have become more lenient, but further research is needed to ensure these policies do not increase crash risk.
✅ ICD Recipients May Self-Regulate Driving: Many patients reduce their time on the road voluntarily, possibly contributing to lower observed crash rates.
✅ Future Research Needs to Leverage Technology: More detailed tracking of driving behavior and ICD-related cardiac events could provide better safety insights.

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Assessing the Risk: ICDs and Driving Safety

After ICD implantation, patients face a temporary driving restriction due to potential risks, including ventricular arrhythmias, lead dislodgement, and inappropriate shocks. These events could cause sudden incapacitation, increasing the risk of serious motor vehicle accidents.

Many guidelines advise stopping driving for three to six months, particularly for secondary prevention ICDs (implanted after a life-threatening arrhythmia). However, limited evidence supports these rules, leading some regions like Canada and Europe to relax restrictions.

To help clarify the risks, researchers examined driving and health records of patients with newly implanted ICDs. The study compared the risk of crashes in ICD recipients versus the general driving population.

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Key Findings: No Clear Crash Risk Increase

The study included 2,595 drivers involved in 3,299 crashes, with a median age of 66 years and 85% male participants. Analysis showed:

• ICD implantation was recorded in 6.4% of pre-crash intervals and 7.4% of control (non-crash) intervals, indicating no significant association between ICD placement and accident risk (adjusted OR 0.86; 95% CI 0.71-1.03).
• Crash responsibility analysis (which eliminates time-on-road bias) found 14 of 22 ICD recipients (64%) were deemed at fault, compared to 51% of non-ICD drivers. This difference was not statistically significant, though it suggests a possible trend toward higher responsibility (adjusted OR 2.20; 95% CI 0.94-5.30).

Overall, ICD recipients did not appear to have an elevated risk of crashing. However, uncertainties in the data mean a small increased risk cannot be ruled out.

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Understanding the Uncertainty: Why More Research Is Needed

Despite the mostly reassuring findings, there are still critical gaps in understanding ICD-related driving risks:

1️⃣ Self-Regulated Driving Behavior:

• Many ICD patients reduce or stop driving voluntarily, which may artificially lower observed crash rates.
• A prior study showed ICD patients had lower crash rates than the general population, but this may reflect reduced driving rather than lower per-mile risk.

2️⃣ Crash Responsibility Uncertainty:

• The study found ICD patients were slightly more likely to be deemed responsible for accidents, though the small sample size limited statistical confidence.
• The confidence intervals were wide, meaning the actual risk could be lower—or significantly higher.

3️⃣ Need for More Precise Data:

• Future studies should track driving hours, crash locations, and real-time ICD data to correlate accidents with cardiac events.
• Wearable or in-vehicle monitoring devices could help assess moment-to-moment risks for ICD patients.

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Policy Implications: Should Driving Rules Be Revisited?

The recent relaxation of driving restrictions for ICD patients—particularly in Canada and Europe—needs ongoing evaluation. While this study suggests no immediate increase in accidents, there remains a potential for hidden risks.

🔹 Clinicians may need to personalize driving advice, especially for patients with high arrhythmic burden or frequent ICD shocks.
🔹 Policymakers should continue to collect and analyze crash data to ensure driving rule changes are not increasing road hazards.
🔹 Future recommendations should integrate technology—such as real-time cardiac monitoring and AI-driven risk assessment tools—to improve individualized driving guidance.

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Conclusion: Reassuring, But Not Definitive

While this study does not show a significant increase in crash risk among ICD patients, uncertainties remain. The need for caution and further research is clear.

For now, ICD recipients should follow medical advice on driving restrictions, but ongoing studies will be crucial in refining guidelines to balance safety with independence. As driving rules continue to evolve, clinicians, traffic safety officials, and policymakers must work together to ensure safe mobility for all drivers.

🚦 Final Thought: The road ahead for ICD patients and driving regulations is still being mapped. This study is an important checkpoint—but not the final destination.

The EU’s AI Act Takes Effect: What Businesses and Consumers Need to Know

The European Union’s Artificial Intelligence Act (AI Act) has officially begun its phased enforcement, with the first set of requirements taking effect on February 2, 2025. This comprehensive legislation establishes strict prohibitions, compliance mandates, and hefty penalties for non-compliance, shaping the future of AI governance in Europe and beyond. The law balances ethical concerns, consumer protection, and innovation, making it a blueprint for global AI regulation.

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🚨 Key Take-Home Points

✅ Banned AI Practices: High-risk AI applications, including social scoring, real-time biometric surveillance, and emotion recognition in workplaces and schools, are now illegal.
✅ Mandatory AI Training: Organizations must train employees at different competency levels to ensure safe and ethical AI use.
✅ Heavy Financial Penalties: Non-compliant businesses face fines of up to €35 million or 7% of global turnover, surpassing even GDPR penalties.
✅ Phased Implementation: The AI Act rolls out in stages through 2027, allowing businesses to adapt.
✅ Impact on Businesses: Financial institutions, AI developers, and cross-border firms must align AI strategies with GDPR and other regulations.
✅ Global Influence: As the first comprehensive AI law, the AI Act is shaping international AI standards and compliance expectations.

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Banned AI Practices: What’s No Longer Allowed?

The AI Act immediately prohibits certain AI systems deemed to pose an unacceptable risk to individuals or society. These include:

• Social Scoring Systems: AI that assesses individuals' trustworthiness based on behavior, background, or personal characteristics.
• Real-Time Biometric Identification: Law enforcement is banned from using AI-driven facial recognition in public spaces, except in severe cases like terrorism threats or kidnappings.
• Biometric Categorization: AI tools that infer sensitive attributes like race, political opinions, religious beliefs, or sexual orientation are now illegal.
• Emotion Recognition in Work and Schools: AI systems attempting to analyze emotions in workplaces, schools, and law enforcement contexts are no longer permitted.
• Manipulative AI: AI designed to coerce, deceive, or exploit individuals—especially those in vulnerable positions—is outlawed.

These bans aim to prevent discrimination, safeguard personal privacy, and protect fundamental human rights in the face of rapidly advancing AI technologies.

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Mandatory AI Training and Compliance

To ensure organizations properly manage AI risks, the AI Act requires companies to implement AI literacy training for employees. This includes:

• Advanced Training for legal, compliance, and AI development teams.
• Intermediate Education for HR professionals and customer service roles interacting with AI.
• Basic Awareness Programs for all employees engaging with AI-driven systems.

Regulatory bodies will audit compliance, with training deficiencies being considered aggravating factors in enforcement actions. This means businesses that fail to educate staff on AI ethics and risks could face stricter penalties.

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Severe Financial Penalties for Non-Compliance

Companies that fail to comply with the AI Act face historic fines—even exceeding those imposed by GDPR. The penalties include:

• €35 million or 7% of global revenue for violating prohibited AI practices.
• 3% of global turnover for failing to meet data governance and transparency requirements.
• 1.5% of turnover for providing regulators with incorrect or misleading information.

These fines underscore the EU’s commitment to strict AI regulation, setting a global benchmark for AI accountability.

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Phased Implementation Timeline

The AI Act is rolling out in stages, ensuring businesses have time to adapt to new compliance measures:

• August 2025: Transparency rules take effect for general-purpose AI models (e.g., chatbots, language models).
• August 2026: Full compliance required for high-risk AI systems in sectors like education, employment, and healthcare.
• August 2027: Regulations expand to all remaining high-risk AI applications, marking full enforcement of the law.

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Impact on Businesses and Financial Sectors

The financial sector faces some of the most immediate challenges. Currently, 73% of asset managers use or plan to use AI for customer risk assessments, fraud detection, and hiring decisions. However, the AI Act bans certain applications, such as:

• AI-driven social scoring for employment or creditworthiness assessments.
• Emotion recognition tools in customer service and hiring.
• AI-based risk profiling methods that lack transparency.

Companies operating in the EU must now align AI strategies with GDPR and other regulations like NIS2 (cybersecurity framework), making compliance even more complex.

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The Global Influence of the AI Act

As the world’s first comprehensive AI regulation, the AI Act is likely to set the standard for AI governance worldwide. Companies operating across multiple jurisdictions will have to harmonize their AI policies, ensuring compliance with the EU’s stringent rules while navigating potential conflicts with U.S. and Asian AI regulations.

The law also raises questions about innovation—while protecting consumer rights and data privacy, some worry that it may slow down AI research and limit the EU’s competitiveness in the global AI market.

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Conclusion

The AI Act represents a bold step in AI regulation, introducing clear prohibitions, strict compliance mandates, and financial consequences for non-compliance. While businesses must navigate new legal complexities, consumers gain greater protection from AI misuse. As enforcement expands, companies and regulators will face ongoing challenges in balancing innovation with ethical AI governance—a debate that will shape the future of AI worldwide.

Key Developments in Cardiovascular Medicine in January 2025

January’s top cardiovascular stories covered a broad spectrum of topics, from pulsed-field ablation concerns to the effects of sugary drinks on health. The leading article focused on J&J’s decision to pause Varipulse cases, while other widely read topics included angiography risks in cardiac arrest patients, GLP-1 drugs for weight loss, and osteoporosis medication risks in dialysis patients. Below is a detailed breakdown of the key stories that captured the most attention this month.

J&J Suspends Varipulse Cases Due to Neurovascular Concerns

Johnson & Johnson halted the use of Varipulse pulsed-field ablation in the U.S. after four neurovascular events were identified during an external evaluation study.

This temporary pause has raised concerns about patient safety and the future of pulsed-field ablation as an alternative to conventional catheter ablation for atrial fibrillation.

Experts emphasize the need for thorough investigations to ensure the long-term safety and efficacy of the technology.

Angiography Risks in OHCA Patients Without STEMI

A Bayesian analysis of two neutral studies (TOMAHAWK and COACT) suggests that immediate angiography in out-of-hospital cardiac arrest (OHCA) patients without ST-elevation myocardial infarction (STEMI) could do more harm than good.

The findings challenge previous assumptions that an aggressive intervention approach is always beneficial.

Careful patient selection is necessary when deciding on early coronary angiography.

Sugary Drinks Linked to Increased Risk of Diabetes and Cardiovascular Disease

A global study confirmed that sugar-sweetened beverages significantly contribute to the rising burden of diabetes and cardiovascular disease (CVD).

Even in regions like sub-Saharan Africa, which were previously less affected by Western dietary habits, sugary drinks are now fueling metabolic disorders.

The findings support stronger public health policies, including potential taxation and regulatory measures, to curb consumption.

GLP-1 Drugs Effective for Weight Loss in People Without Diabetes

A new review of clinical trials found that GLP-1 receptor agonists such as Wegovy, Zepbound, and Ozempic help non-diabetic individuals lose weight effectively.

With multiple drugs already approved and more in development, the findings suggest that GLP-1 therapies could reshape obesity management, offering a viable alternative to bariatric surgery for some patients.

The study also emphasized the cardiovascular benefits of weight loss with GLP-1 drugs.

Surgeons Align with European Guidelines on Revascularization in Chronic Coronary Syndrome (CCS)

The Society of Thoracic Surgery (STS), the American Association for Thoracic Surgery (AATS), and other major surgical organizations have formally supported the European Society of Cardiology’s (ESC) stance on revascularization for Chronic Coronary Syndrome (CCS).

This endorsement reinforces coronary artery bypass grafting (CABG) as the preferred strategy in many high-risk patients compared to percutaneous coronary intervention (PCI).

CABG is particularly indicated for patients with left main coronary artery disease, multivessel coronary artery disease (especially in diabetics), and those with reduced left ventricular function.

Studies have consistently shown that CABG offers better long-term survival, lower rates of repeat procedures, and improved protection against heart attacks.

Surgeons argue that the shift toward PCI has often prioritized convenience over durability, making CABG a more evidence-backed option in complex cases.

Osteoporosis Drug Denosumab Linked to Increased MACE in Dialysis Patients

A study found that denosumab (Prolia), a common osteoporosis treatment, is associated with a 36% higher risk of major adverse cardiovascular events (MACE) in dialysis-dependent patients compared to bisphosphonates.

Researchers urged caution when prescribing denosumab in this population.

Alternative osteoporosis management strategies may be safer for patients with chronic kidney disease (CKD).

Surgical Societies Take a Stand Against Professional Misconduct

Professional misconduct, including bullying, harassment, and disrespect, has been a persistent issue in the surgical field.

The European Association for Cardio-Thoracic Surgery (EACTS) and the STS have introduced new professional conduct policies aimed at fostering a safer, more respectful workplace.

Surgical training has traditionally been associated with rigorous expectations and long hours, sometimes fostering a culture of intimidation.

Studies show that toxic workplace environments contribute to higher burnout rates, mental health issues, and job dissatisfaction.

The new policies emphasize zero tolerance for harassment, clear reporting mechanisms, and mandatory training for all surgical professionals.

These changes are expected to improve teamwork, reduce burnout, and enhance surgical outcomes.

Coronary Sinus Reducer Overlooked in Stable Angina Treatments

The Coronary Sinus Reducer, a device used to relieve angina symptoms in patients with refractory coronary artery disease, was not included in a major review of stable angina treatments.

This exclusion surprised experts, as sham-controlled trials have shown the device significantly improves patient-reported symptoms.

The omission highlights the ongoing debate about integrating new technologies into clinical practice guidelines.

Private Equity Ownership of Hospitals Worsens Patient Experience

A study revealed that hospitals acquired by private equity firms see a decline in patient satisfaction and a shift toward profit-driven management.

Researchers called for greater transparency, oversight, and regulation to prevent quality of care from deteriorating under private ownership models.

The findings add to the growing debate over the corporatization of healthcare and its impact on patient outcomes.

Kidney Function Changes With Finerenone Shouldn’t Stop Treatment

Finerenone (Kerendia; Bayer AG), a drug used to treat chronic kidney disease (CKD) in heart failure patients, is associated with an initial decline in estimated glomerular filtration rate (eGFR).

Experts emphasized that this early drop is not a reason to discontinue treatment.

Long-term benefits outweigh initial changes, supporting continued use of finerenone for renal and cardiovascular protection.