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Valvular Heart Disease

RCT: Early Surgical AVR Improved Outcomes in Asymptomatic Severe Aortic Stenosis

6 Oct, 2024 | 16:29h | UTC

Background: Severe aortic stenosis (AS) is a prevalent valvular heart disease requiring intervention in symptomatic patients. The optimal timing for surgical aortic valve replacement (AVR) in truly asymptomatic patients with severe AS and normal left ventricular (LV) systolic function remains uncertain and is under investigation.

Objective: To determine whether early surgical AVR improves clinical outcomes compared to conservative management with watchful waiting in asymptomatic patients with severe AS and normal LV ejection fraction (LVEF ≥50%).

Methods: The AVATAR trial was a multicenter, randomized controlled trial involving 157 low-risk, asymptomatic patients (mean age 67 years, 57% men) with severe AS and normal LVEF. Patients were randomized to early surgical AVR (n=78) or conservative treatment (n=79). All participants had negative exercise stress tests to confirm asymptomatic status. The primary composite endpoint included all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure (HF). Secondary outcomes encompassed individual components of the primary endpoint, cardiovascular death, serious adverse events, and procedural metrics.

Results: Over a median follow-up of 63 months, the primary composite endpoint occurred in 23.1% of the early surgery group versus 46.8% of the conservative group (hazard ratio [HR] 0.42; 95% confidence interval [CI], 0.24–0.73; P=0.002). All-cause mortality was significantly lower in the early surgery group (16.7% vs. 34.2%; HR 0.44; 95% CI, 0.23–0.85; P=0.012). Unplanned HF hospitalizations were also reduced (4.0% vs. 17.0%; HR 0.21; 95% CI, 0.06–0.73; P=0.007). There were no significant differences in stroke rates between the groups. Serious adverse events occurred less frequently in the early surgery group (26.4% vs. 49.4%; P=0.013). Sudden cardiac death was less common in the early surgery group, though not statistically significant (5.1% vs. 11.4%; P=0.17).

Conclusions: Early surgical AVR in asymptomatic patients with severe AS and normal LVEF significantly improved clinical outcomes, including reductions in all-cause mortality and HF hospitalizations, compared to conservative management.

Implications for Practice: These findings support considering early surgical AVR in truly asymptomatic patients with severe AS and normal LV function to reduce the risk of adverse events and improve long-term outcomes. Clinicians should weigh the benefits of early intervention against surgical risks, emphasizing careful patient selection and monitoring.

Study Strengths and Limitations: Strengths of the study include its randomized design, extended follow-up period, and strict inclusion of truly asymptomatic patients confirmed by negative exercise testing. Limitations involve a smaller sample size than initially projected, potential impacts of the COVID-19 pandemic on follow-up and healthcare access, and early termination of enrollment, which may affect the generalizability of the results.

Future Research: Further large-scale randomized trials are needed to validate these findings and explore the role of early intervention strategies, including transcatheter aortic valve implantation (TAVI), in asymptomatic patients with severe AS.

Reference: Banovic M, et al. (2024). Aortic Valve Replacement vs. Conservative Treatment in Asymptomatic Severe Aortic Stenosis: Long-Term Follow-Up of the AVATAR Trial. European Heart Journal. DOI: https://doi.org/10.1093/eurheartj/ehae585

 

RCT: PCI Reduces Major Adverse Cardiac Events in Patients Undergoing TAVI with Significant Coronary Artery Disease

14 Sep, 2024 | 19:09h | UTC

Background:

Severe aortic stenosis and coronary artery disease (CAD) frequently coexist, particularly in the elderly population. Approximately 50% of patients undergoing transcatheter aortic valve implantation (TAVI) have concurrent CAD. The optimal management of significant coronary lesions in patients undergoing TAVI remains uncertain, with guidelines providing no clear recommendations. Understanding whether percutaneous coronary intervention (PCI) improves outcomes in this setting is crucial for guiding clinical practice.

Objective:

To evaluate whether routine PCI of physiologically significant coronary lesions improves clinical outcomes compared to conservative management in patients with stable CAD undergoing TAVI.

Methods:

  • Design: International, multicenter, open-label, randomized controlled trial (NOTION-3).
  • Participants: 455 patients with severe symptomatic aortic stenosis scheduled for TAVI and at least one significant coronary lesion (defined as fractional flow reserve [FFR] ≤0.80 or diameter stenosis ≥90%).
  • Interventions:
    • PCI Group (n=227): Underwent PCI of all eligible lesions followed by TAVI.
    • Conservative Treatment Group (n=228): Received TAVI without prior PCI.
  • Primary Endpoint: Major adverse cardiac events (MACE), a composite of death from any cause, myocardial infarction (MI), or urgent revascularization.
  • Secondary Endpoints: Included individual components of the primary endpoint, bleeding events, stroke, hospital admissions for heart failure, and procedural complications.
  • Follow-Up: Median of 2 years (interquartile range, 1 to 4 years).

Results:

  • Baseline Characteristics: Median age was 82 years; 67% were men; median Society of Thoracic Surgeons–Procedural Risk of Mortality (STS-PROM) score was 3%.
  • Primary Endpoint (MACE):
    • Occurred in 26% of patients in the PCI group versus 36% in the conservative group.
    • Hazard Ratio (HR): 0.71 (95% Confidence Interval [CI], 0.51 to 0.99; P=0.04), indicating a 29% relative risk reduction with PCI.
  • Components of MACE:
    • Myocardial Infarction:
      • Lower incidence in the PCI group.
    • Urgent Revascularization:
      • Reduced need in the PCI group.
  • All-Cause Mortality:
    • No significant difference between groups.
  • Bleeding Events:
    • Higher in the PCI group (28% vs. 20%; HR, 1.51; 95% CI, 1.03 to 2.22).
    • Bleeding assessed according to Valve Academic Research Consortium–2 criteria.
  • Procedural Complications:
    • PCI-related complications occurred in 3% of patients in the PCI group.
  • Safety Endpoints:
    • Similar rates of stroke and stent thrombosis between groups.
    • Acute kidney injury was less frequent in the PCI group (5% vs. 11%; HR, 0.45; 95% CI, 0.23 to 0.89).

Conclusions:

In patients with stable CAD and severe symptomatic aortic stenosis undergoing TAVI, performing PCI on significant coronary lesions resulted in a statistically significant reduction in MACE over a median follow-up of 2 years compared to conservative management. The benefit was primarily due to reductions in myocardial infarction and urgent revascularization rates. However, this advantage was accompanied by an increased risk of bleeding events.

Clinical Implications:

  • Patient Selection: PCI should be considered in patients with physiologically significant coronary lesions (FFR ≤0.80 or diameter stenosis ≥90%) undergoing TAVI.
  • Risk–Benefit Analysis: Clinicians should balance the reduction in MACE against the increased bleeding risk when deciding on PCI.
  • Treatment Strategy: The findings support a strategy of routine revascularization in this patient population to improve cardiovascular outcomes.
  • Future Considerations: Further research is needed to determine the optimal timing of PCI relative to TAVI and to identify which patient subgroups may derive the most benefit.

Recommendations:

  • Guideline Update: The results may inform future guidelines to provide clearer recommendations on managing CAD in patients undergoing TAVI.
  • Individualized Care: Decisions regarding PCI should be individualized, considering patient comorbidities, anatomical complexity, and bleeding risk.
  • Antithrombotic Therapy: Attention to antiplatelet and anticoagulation strategies is important to mitigate bleeding risks.

Study Limitations:

  • Exclusion of patients with recent acute coronary syndromes and left main coronary artery disease limits the generalizability.
  • Changes in antithrombotic regimens over the study period reflect evolving clinical practice but may affect outcomes.
  • Majority of patients had low to intermediate SYNTAX scores, so results may not apply to those with more complex CAD.

Final Note:

The NOTION-3 trial provides valuable evidence supporting the use of PCI in patients with significant CAD undergoing TAVI, emphasizing the importance of comprehensive cardiovascular care in this high-risk population.

Reference: Lønborg, J., et al. (2024). PCI in patients undergoing transcatheter aortic-valve implantation. New England Journal of Medicine. DOI: https://doi.org/10.1056/NEJMoa2401513

 

RCT: Transcatheter Repair Noninferior to Mitral-Valve Surgery for Secondary Mitral Regurgitation

12 Sep, 2024 | 12:13h | UTC

Study Design and Population: This noninferiority trial, conducted in Germany, enrolled 210 patients with heart failure and secondary mitral regurgitation who remained symptomatic despite medical therapy. Patients were randomized to undergo either transcatheter edge-to-edge repair or mitral-valve surgery, with outcomes assessed over a one-year period.

Main Findings: Transcatheter repair was found to be noninferior to mitral-valve surgery regarding the primary efficacy outcome—a composite of death, heart failure hospitalization, mitral-valve reintervention, assist device implantation, or stroke at one year (16.7% in the transcatheter group vs. 22.5% in the surgery group; mean difference, -6%; 95% CI, -17 to 6; P<0.001 for noninferiority). The transcatheter group experienced fewer major adverse events within 30 days (14.9% vs. 54.8%; mean difference, -40%; 95% CI, -51 to -27; P<0.001).

Implications for Practice: Transcatheter edge-to-edge repair offers a similar efficacy to mitral-valve surgery at one year with a lower rate of short-term adverse events, suggesting it may be a suitable alternative, particularly for patients with higher surgical risk.

Reference: Baldus, S. et al. (2024). Transcatheter repair versus mitral-valve surgery for secondary mitral regurgitation. New England Journal of Medicine. DOI: http://doi.org/10.1056/NEJMoa2408739

 

RCT: Routine Protamine Administration Enhances Hemostasis and Reduces Vascular Complications in TAVI – JAMA Cardiol

17 Aug, 2024 | 19:09h | UTC

Study Design and Population: The ACE-PROTAVI trial was a double-blind, placebo-controlled randomized clinical trial conducted at three Australian hospitals. It involved 410 patients (median age 81 years) undergoing transfemoral transcatheter aortic valve implantation (TAVI). The trial evaluated the efficacy and safety of routine protamine administration versus placebo.

Main Findings: Patients receiving protamine showed a higher rate of successful hemostasis (97.9% vs. 91.6%) and a significantly shorter time to hemostasis (median 181 vs. 279 seconds). Protamine administration also led to a reduced risk of composite vascular complications (5.2% vs. 12.8%), primarily due to fewer minor vascular events. No adverse events were associated with protamine.

Implications for Practice: Routine protamine administration after TAVI improves hemostasis, reduces minor vascular complications, and shortens procedural and postprocedural recovery times, suggesting it should be considered in standard TAVI protocols.

Reference: Vriesendorp, P. A., Nanayakkara, S., Heuts, S., et al. (2024). Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI Randomized Clinical Trial. JAMA Cardiology. Published online August 14, 2024. DOI: 10.1001/jamacardio.2024.2454.

 

Single-Arm Study: Evaluation of transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation – The Lancet

25 May, 2024 | 19:45h | UTC

This article discusses the ALIGN-AR study, a prospective, multicenter, single-arm trial conducted across 20 US sites. The study enrolled 180 high-risk patients suffering from moderate-to-severe or severe symptomatic aortic regurgitation, who were treated with the Trilogy transcatheter heart valve. The average age of participants was 75.5 years, with a roughly equal gender distribution among the 180 participants. The primary safety endpoint of the study was assessed against a prespecified performance goal of 40.5%, with results showing a 27% event rate, which was considered non-inferior (p<0.0001). Additionally, the primary efficacy endpoint, 1-year all-cause mortality, was 7.8%, significantly below the performance goal of 25%, also demonstrating non-inferiority (p<0.0001). The study reported a 95% technical success rate with adverse events such as new pacemaker implantation occurring in 24% of the patients. These findings suggest that the Trilogy transcatheter heart valve is a viable and effective option for high-risk patients, achieving favorable short-term clinical and hemodynamic outcomes. Further follow-up is necessary to determine long-term results and effects on left ventricular remodeling.

 

Reference (link to abstract – $ for full-text):

Torsten P Vahl et al. (2024). Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. The Lancet, Volume (Issue), Pages. DOI: https://doi.org/10.1016/S0140-6736(23)02806-4

 

M-A: Reduced risk of infective endocarditis following dental procedures with antibiotic prophylaxis in high-risk individuals

26 Apr, 2024 | 12:07h | UTC

Study Design and Population:

This systematic review and meta-analysis evaluated the impact of antibiotic prophylaxis on the incidence of infective endocarditis following invasive dental procedures. Researchers analyzed data from 1,152,345 cases sourced from PubMed, Cochrane-CENTRAL, Scopus, and other databases up to May 2023. The study included various research designs, such as case-control, cohort, and time-trend studies, assessing the effectiveness of antibiotic prophylaxis across different risk groups.

 

Main Findings:

The meta-analysis revealed that antibiotic prophylaxis significantly lowers the risk of infective endocarditis among individuals at high risk (pooled relative risk, 0.41; 95% CI, 0.29-0.57), with consistent findings across studies of good quality. However, the effectiveness of prophylaxis in individuals at moderate or low/unknown risk remains unsupported by sufficient evidence. Time-trend studies provided mixed results, with some indicating no change or an increase in infective endocarditis incidence post-guideline changes in 2007.

 

Implications for Practice:

The findings support the continued use of antibiotic prophylaxis for high-risk individuals undergoing invasive dental procedures, aligning with current guidelines from the American Heart Association and European Society of Cardiology. The lack of clear benefits in moderate and low-risk groups suggests a need for further research to optimize prophylaxis guidelines and ensure effective risk stratification in clinical practice.

Reference (link to abstract – $ for full-text):

Sperotto, F. et al. (2024). Antibiotic Prophylaxis and Infective Endocarditis Incidence Following Invasive Dental Procedures: A Systematic Review and Meta-Analysis. JAMA Cardiol, Published online April 6, 2024. DOI: 10.1001/jamacardio.2024.0873

Registry Analysis | Incidence and impact of pacemaker implantation after TAVR with self-expanding valves

8 Aug, 2023 | 13:29h | UTC

Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves – JACC: Cardiovascular Interventions (link to abstract – $ for full-text)

Commentaries:

Permanent pacemakers after TAVR: Tracking the impact of modern self-expanding valves – Cardiovascular Business

Pacemaker Implantation Still Risky, Not Rare With Self-Expanding TAVI Devices – TCTMD

 

BSH guideline for anticoagulant management of pregnant individuals with mechanical heart valves

2 Aug, 2023 | 14:01h | UTC

British Society for Haematology guideline for anticoagulant management of pregnant individuals with mechanical heart valves – British Journal of Haematology

 

Debate | Do all patients with asymptomatic severe aortic stenosis need valve replacement?

2 Aug, 2023 | 13:58h | UTC

Great debate: all patients with asymptomatic severe aortic stenosis need valve replacement – European Heart Journal

 

Commentary on Twitter

 

Consensus Paper | Diagnosis and management of infective endocarditis in adults

1 Aug, 2023 | 14:34h | UTC

Guidelines for Diagnosis and Management of Infective Endocarditis in Adults: A WikiGuidelines Group Consensus Statement – JAMA Network Open

 

Registry Analysis | Similar 1-year mortality rates post-TAVR in cardiogenic shock patients surviving 30-day mark

31 Jul, 2023 | 13:47h | UTC

Outcomes of transcatheter aortic valve replacement in patients with cardiogenic shock – European Heart Journal

Commentary: TAVR Found Safe and Effective in Patients With Cardiogenic Shock: An NCDR Analysis – American College of Cardiology

 

Commentary on Twitter

 

Cohort Study | Examining patient demographics, microbiology, and mortality in infectious endocarditis after TAVI

25 Jul, 2023 | 13:48h | UTC

Patient characteristics, microbiology, and mortality of infective endocarditis after transcatheter aortic valve implantation – Clinical Infectious Diseases

 

Case Series | Cutibacterium acnes endocarditis often misdiagnosed due to absence of typical symptoms and delayed culture results

17 Jul, 2023 | 13:31h | UTC

Clinical Characteristics and Outcomes of Patients With Cutibacterium acnes Endocarditis – JAMA Network Open

 

M-A | Family screening for bicuspid aortic valve and aortic dilatation

5 Jul, 2023 | 01:01h | UTC

Family screening for bicuspid aortic valve and aortic dilatation: a meta-analysis – European Heart Journal

 

Commentary on Twitter

 

Cohort Study | Risk and outcome of infective endocarditis in streptococcal bloodstream infections according to streptococcal species

22 Jun, 2023 | 15:09h | UTC

Risk and Outcome of Infective Endocarditis in Streptococcal Bloodstream Infections according to Streptococcal Species – Clinical Microbiology

 

RCT | No superior recovery with minithoracotomy over sternotomy in mitral valve repair

20 Jun, 2023 | 12:51h | UTC

Minithoracotomy vs Conventional Sternotomy for Mitral Valve Repair: A Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual Abstract

Commentary: Mitral valve repair: How a minimally invasive approach compares to conventional surgery – Cardiovascular Business

 

Review | Treatment of Enterococcus faecalis infective endocarditis

30 May, 2023 | 11:54h | UTC

Treatment of Enterococcus faecalis Infective Endocarditis: A Continuing Challenge – Antibiotics

 

Scientific Statement | Acute heart failure and valvular heart disease

30 May, 2023 | 11:53h | UTC

Acute Heart Failure and Valvular Heart Disease: A Scientific Statement of the Heart Failure Association (HFA), the Association for Acute Cardi-Vascular Care (ACVC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC – European Journal of Heart Failure

 

RCT | Apixaban fails to match warfarin in preventing valve thrombosis in On-X mechanical heart valve patients

22 May, 2023 | 13:44h | UTC

Apixaban or Warfarin in Patients with an On-X Mechanical Aortic Valve – NEJM Evidence

Commentary: Apixaban or Warfarin in Patients With On-X Mechanical Aortic Valve – American College of Cardiology

 

Commentary on Twitter

 

Formal consensus study on surgery to replace the aortic valve in adults aged 18–60 years

10 May, 2023 | 15:38h | UTC

Formal consensus study on surgery to replace the aortic valve in adults aged 18–60 years – Heart

 

Commentary on Twitter

 

Review | Challenges in cardiology: diagnosis of native and prosthetic valve endocarditis

9 May, 2023 | 14:19h | UTC

Challenges in cardiology: diagnosis of native and prosthetic valve endocarditis – European Heart Journal Supplements

See all articles in the series here

 

Review | DOACs and rheumatic valvulopathy: always a red light?

9 May, 2023 | 14:15h | UTC

DOACs and rheumatic valvulopathy: always a red light? – European Heart Journal Supplements

See all articles in the series here

 

Expert Panel | Appropriate use criteria for the management of aortic stenosis

5 May, 2023 | 15:22h | UTC

Appropriate Use Criteria for the Management of Aortic Stenosis: Insight From the Japanese Expert Panel – JACC: Asia

 

Perspective | Proposal of a model of care for outpatient antimicrobial therapy for infective endocarditis

12 Apr, 2023 | 13:08h | UTC

Outpatient Parenteral Antimicrobial Therapy for Infective Endocarditis—Model of Care – Antibiotics

 

Commentary on Twitter

 

Rheumatic heart disease: JACC focus seminar

6 Apr, 2023 | 13:17h | UTC

Rheumatic Heart Disease: JACC Focus Seminar – Journal of the American College of Cardiology

 

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