CLASP IID: The PASCAL system is a safe and beneficial therapy for severe degenerative mitral regurgitation

Key Points:

  • The MitraClip system has been established as a robust platform for transcatheter repair of both degenerative and functional mitral regurgitation. However, it has not been compared against more novel therapies (such as the PASCAL system). The CLASP IID trial is the first RCT to directly compare two transcatheter valve repair therapies for degenerative MR.
  • The PASCAL system met the primary safety and effectiveness endpoints of this pivotal noninferiority trial. There was a low composite MAE rate (3.4%) at 30 days, and 97.7% of patients achieved sustained reduction of MR (≤ 2+) at 6 months.
  • This trial establishes the PASCAL system as a safe, beneficial therapy for patients with significant symptomatic DMR and prohibitive surgical risk.

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PROTECTED TAVR: No Overall Stroke Reduction With Embolic Protection Devices in TAVR, But Fewer Disabling Strokes

Key Points:

  • Stroke is a feared complication of TAVR. However, the potential impact of cerebral embolic protection (CEP) devices is unclear. The PROTECTED TAVR study was a post-market RCT to examine the utility of CEP devices in TAVR patients across all risk categories.
  • CEP device use did not result in a significant difference in all strokes at 72 hours or discharge, but it did reduce the rate of disabling strokes in secondary analysis.
  • CEP device use was safe, with no difference in the safety composite of all-cause mortality and stroke and only a 0.1% risk of vascular complication related to CEP.

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Study Shows Aortic Valve Replacement Was Associated With Better Outcomes in Patients with Low-Gradient Aortic Stenosis and Preserved Left Ventricular Ejection Fraction Compared With High-Gradient Aortic Stenosis Analysis of PARTNER 2A randomized trial and SAPIEN 3 registry

A recent study by Dr. Salaun, published in Circulation: Cardiovascular Interventions, demonstrated that aortic valve replacement in patients with the low gradient (LG, defined as mean gradient <40 mmHg) severe aortic stenosis (AS) and preserved ejection fraction (EF) has resulted in better outcomes versus in those with the high gradient (HG, defined as a mean transvalvular gradient (MG) 40 mmHg) AS. Also, the study revealed that patients with classical low flow, low gradient (CLF-LG, defined as MG <40 mmHg and LVEF <50%) AS were at higher risk of death, rehospitalization, or stroke at 2 years.

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The Sarcomeric Human Cardiomyopathy Registry: Race Associated with Disease Expression and Clinical Outcomes Among Patients with Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy and race: differences in disease expression, inequitable care provision, and disparate clinical outcomes

Hypertrophic cardiomyopathy (HCM) is the most common inherited genetic disorder of the myocardium, and the number one culprit of sudden cardiac death in athletes, particularly African Americans.

“Is race associated with differential disease expression, inequitable care provision, or disparate clinical outcomes among patients with hypertrophic cardiomyopathy?”

In order to answer the above question, Lauren A. Eberly, et al. studied 2,467 patients with hypertrophic cardiomyopathy. In a retrospective cohort study, black and white patients with hypertrophic cardiomyopathy from the US-based sites of the Sarcomeric Human Cardiomyopathy Registry from 1989 through 2018 compared in terms of baseline characteristics; genetic architecture; adverse outcomes such as cardiac arrest, cardiac transplantation or left ventricular assist device implantation, cardioverter-defibrillator implantation, all-cause mortality, atrial fibrillation, stroke,  prevalence and likelihood of developing heart failure; and receiving septal reduction therapies.

According to the results of this study (8.3 percent black; 91.7 percent white), published in the JAMA CARDIOLOGY (December 2019), compared with white patients, black patients with HCM were younger (mean age, 36.5 versus 41.9 years), were less likely to have sarcomere mutations (26.1 versus 40.5 percent), had a higher prevalence of New York Heart Association (NYHA) class III or IV heart failure at presentation (22.6 versus 15.8 percent) and were more prone to developing heart failure (hazard ratio, 1.45). Lower rates of genetic testing (26.1 versus 40.5 percent) have been observed in black patients. Although there were no racial differences in implantation of implantable cardioverter-defibrillators, the invasive septal reduction was less common among African Americans (14.6 versus 23 percent). Nevertheless, Black patients had fewer incidents of atrial fibrillation (35 [17.1 percent] versus 608 [26.9 percent].

The results of this study were in accordance with the previous studies that mentioned a higher prevalence of complicated hypertrophic cardiomyopathy in African Americans in contrast to the lower prevalence of HCM in this community.  Eberly, et al. believe that racial differences in disease expression and adverse clinical outcomes are not only because of different characteristics of the disease in African Americans but also inequities in clinical care provision might be responsible for these observed differences.

New-Onset AF After TAVR linked To Worse Long-Term Outcomes Compared With Patients With Pre-Existing AF and No AF New-onset AF associated with a higher rate of death, stroke, bleeding and heart failure hospitalizations after TAVR

A registry-based cohort study including 72,660 Medicare patients with and without atrial fibrillation (AF) who underwent non-apical transcatheter aortic valve replacement (TAVR) from 2014 to 2016, has shown that, TAVR patients with new-onset AF have the highest rate of all-cause mortality (32%) compared to patients with pre-existing or no AF (23.3% and 12.8%, respectively). New-onset AF was also associated with an increased risk of bleeding, stroke and heart failure (HF) hospitalizations.

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SCOPE I: ACURATE Neo (Self-Expanding TAVR System) Struggles to Have An Edge On SAPIEN 3 (Balloon-Expandable TAVR System)

Results of a randomized trial presented at TCT 2019 and simultaneously published in The Lancet, showed that TAVR with the self-expanding ACURATE neo (Boston Scientific) did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 (Edwards Lifesciences) in terms of early safety and clinical efficacy outcomes.

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Meta-analysis Shows Reduced 1-Year Mortality with TAVR in Low-Risk Severe AS Patients

In a meta-analysis of RCTs comparing TAVR (Transcatheter Aortic Valve Replacement) versus SAVR (Surgical Aortic Valve Replacement) in low-risk patients with severe AS, TAVR was associated with a significantly lower risk of all-cause and cardiovascular mortality at 1 year follow up. The study conducted by Kolte was recently published in the Journal of American College of Cardiology.

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STS/ACC TVT Registry: Higher Volume Associated with Better TAVR Outcomes

Recent updates from the Centers for Medicare & Medicaid Services (CMS) maintain the volume requirements of the transcatheter aortic-valve replacement (TAVR) programs to qualify for reimbursement. In corroborate with the CMS updates, the latest data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry by Dr. Sreekanth Vemulapalli et al., published in the New England Journal of Medicine, revealed lower 30-day mortality at hospitals with a high procedural volume.

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Genetic Study Shows LPA Associated with Calcific Aortic Valve Stenosis and Increased Aortic Valve Microcalcification in First Degree Relatives

A study led by Nicolas Perrot published in JAMA Cardiology showed that a genetically elevated lipoprotein A (LPA) levels was associated with an increased risk of calcific aortic valve stenosis (CAVS). The evidence presented in this study supports the use of LPA screening for calcific aortic valve stenosis.

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PARTNER 3 Trial: Lower Risk of Death, Stroke and Rehospitalization in Patients with Severe Aortic Stenosis and Low Surgical Risk Treated with TAVR

A randomized controlled trial led by Dr. M.J. Mack, published in the New England Journal of Medicine, showed that in patients with severe aortic stenosis and a low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) with a balloon expandable valve was associated with a lower risk of stroke, death or rehospitalization by 1 year when compared to surgery.

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Recently Released Joint Statement Proposes New Model of Care for Patients with Valvular Heart Disease

A joint report that proposes an integrated model of care for patients with valvular heart disease (VHD) was recently released by the American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Society for Cardiovascular Angiography and Interventions (SCAI) and Society of Thoracic Surgeons (STS). This collaboration was published with the aim of optimizing the care received by patients with VHD.

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Randomized Trial Shows That Transcatheter Aortic-valve Replacement is Non-inferior to Surgery in Low Risk Patients

A study by Dr. Jeffrey Popma and colleagues published in the New England Journal of Medicine showed that transcatheter aortic-valve replacement (TAVR) was non-inferior to surgery with respect to death or the occurrence of a disabling stroke by 24 months in the low-risk group of patients with aortic stenosis. Previous studies showed that in patients with severe aortic stenosis who were at high risk of complications or death from surgery, TAVR with a self-expanding supra-annular bioprosthesis had better outcomes than medical therapy or surgery. However, there was not enough evidence to advocate the use of TAVR instead of surgery in a younger, healthier population. The authors aimed to address this knowledge gap through this study.

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Stress Echo Is Losing Its Prognostic Value in Asymptomatic Aortic Stenosis

Neither increase in mean pressure gradient (MPG) nor systolic pulmonary artery pressure (SPAP) at peak exercise predicts outcomes in patients with asymptomatic aortic stenosis (AS) according to a study published in JACC Cardiovascular Imaging.

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Discharging Patients Is Safe, the Next Day After Minimalist TAVR

In a recent study published in the Journal of the American College of Cardiology (JACC), it was found that patients undergoing uncomplicated TAVR have a safe next-day discharge (NDD) profile with no difference in 30-day mortality rate in comparison to an increased length of hospital stay. In addition, the study also highlighted better 1-year clinical outcomes in patients as compared to non-NDD group. Continue reading

Assessment of Long-term Outcomes in Patients Undergoing SAVR

A contemporary cohort study recently published in Journal of the American College of Cardiology  highlighted the clinical significance of age and other associated comorbidities in determining the clinical outcome in patients undergoing surgical aortic valve replacement (SAVR). The 10-year mortality rate was found to be considerably high in elderly SAVR recipients of a bioprosthetic valve and almost one-third of the population exhibited subclinical structural valve degeneration (SVD). Continue reading

Leaflet thrombosis in transcatheter and surgical bioprosthetic aortic valves Dr. Raj R. Makkar and Dr. C. Michael Gibson Discuss

Silent cerebral microbleeds during TAVR Dr. Eric Van Belle and Dr. Serge Korjian Discuss

Intersection of coronary artery disease and TAVR Dr. Duane Pinto, Dr. James Hermiller and Dr. C. Michael Gibson Discuss

Bivalirudin vs UFH in patients with AFib in TAVR Dr. Usman Baber and Dr. C. Michael Gibson Discuss: BRAVO-3

State of the art in TAVR Dr. Duane Pinto, Dr. Michael Reardon, Dr. James Hermiller and Dr. C. Michael Gibson Discuss