A tweet from John Mandrola, MD

Surgeries & Interventions

Renal Denervation’s Comeback

Two late-breaking studies presented at the annual TCT meeting showed that renal denervation safely and effectively lowered blood pressure among patients with treatment-resistant hypertension. 

Renal denervation burns nerves in the blood vessels surrounding the kidneys to dampen the sympathetic nervous system and decrease blood pressure. Enthusiasm for renal denervation waned after Medtronic’s Symplicity 3 trial failed to meet its target endpoint in 2014.

New data suggests renal denervation may be making a comeback. Both Medtronic and Recor Medical presented randomized, sham-controlled data demonstrating the safety and efficacy of their respective renal denervation devices. 

• ReCor’s ultrasound-powered Paradise device was tied to an 8 mmHg drop in ambulatory systolic BP readings at six months, compared to 2mmHg in the control arm (N=224). Participants also experienced similar reductions in the nighttime, 24-hour, and office readings.
  
• Medtronic’s Symplicity device also showed promising outcomes. At 3 years, the Symplicity group saw in-office systolic blood pressure drop by 22.1 mmHg, with similar trends in the 24-hour ambulatory group. 

The Takeaway

Renal denervation continues to be a promising solution for patients with treatment-resistant hypertension. While previous studies may have fallen short and more research might be needed, physicians and regulators can have renewed confidence that Medtronic’s Symplicity system and ReCor’s Paradise device lower blood pressure.

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The Wire

• Edwards’ SAPIEN 3 Ultra RESILIA: The FDA approved Edwards Lifesciences’ latest transcatheter aortic valve, the SAPIEN 3 Ultra RESILIA. The device incorporates Edwards’ trademark RESILIA tissue – pericardial tissue from cows that is treated with anti-calcification technology – to extend durability, prevent deterioration, and block calcium build-up. The system is already available in 75 countries, and launches in the US later this year through a “limited release.”

• Boston Scientific’s TAVR Device Misses Mark: An NEJM-published study found that Boston Scientific’s Sentinel device – a net-like contraption designed to intercept arterial debris that comes loose during TAVR procedures – did not reduce patients’ stroke risk. Three thousand patients who underwent either traditional TAVR or TAVR with the Sentinel device showed similar stroke rates (2.3% vs. 2.9%), as well as similar death rates (0.5% vs. 0.3%). However, secondary analysis showed that Sentinel was associated with a decreased incidence of disabling stroke (0.5% vs. 1.3%). 

• Milrinone’s Heart Failure Advantage: A new study in JCF found that milrinone was better at preventing death than dobutamine among HF patients. Researchers found that survival improved with chronic IV milrinone therapy compared to dobutamine in 248 advanced heart failure patients (1-year mortality: 58% vs 84%). The authors attributed milrinone’s superior survival to the simultaneous use of beta-blockers, which are usually not prescribed concomitantly with dobutamine.

• Preventing Sudden Cardiac Death: A study examining hypertrophic cardiomyopathy (HCM) – the major cause of sudden cardiac death in young people – suggests cardiac screening could catch early warning signs and prevent mortality. For their study, the Swedish researchers analyzed data (including clinical symptoms, medical & family history, ECG data, autopsy reports, and family interviews) from 38 cases of HCM-associated sudden cardiac deaths (mean age 22 years). They discovered that 87% of cases had one or more abnormalities prior to death, and most sought medical care before they died. 

• Edwards’ PASCAL ‘Not Inferior’ to MitraClip: Days after receiving FDA approval, new data shows that Edwards Lifesciences’ PASCAL transcatheter edge-to-edge repair (TEER) system held its own against Abbott’s MitraClip system. The JACC-published study shows that PASCAL was as effective as the MitraClip, with 96.5% and 96.8% of patients achieving mitral regurgitation grade of 2+ or less. Both systems also achieved similar safety profiles, with major adverse event rates of 3.4% and 4.8%. 

• Abbott’s Gen 4 MitraClip: On that note, results from a prospective study including 1k patients reinforced the safety and efficacy of Abbott’s fourth-generation MitraClip device. The study revealed that mitral regurgitation was reduced to “mild” or better in 91% of patients, with low adverse event rates (1.3% all-cause mortality at 30 days). Patients also reported strong quality of life improvements from baseline. The MitraClip G4 system offers more clip sizes, a greater coaptation area, and more advanced “grippers” for leaflet grasping. 

• Moving Away from BMI: Medscape published a thinkpiece in which Sylvia Gonsahn-Bollie, MD argues that BMI is a flawed reference for health status. She notes that weight bias continues to prevent people living with obesity from receiving life-enhancing obesity therapies, because once their BMI is “normal,” many patients lose coverage for their obesity medication, despite needing long-term metabolic support. If BMI must be used, she contends, then the reference chart ought to be an adjusted chart based on age, race, ethnicity, biological sex, and obesity-related conditions.

• Impella Heart Pump Survival: A three-year study in Japan demonstrated that Abiomed’s Impella heart pump showed strong survival rates among AMI cardiogenic shock patients (AMICS). Among 293 Impella-supported AMICS patients, 81% survived by 30 days (compared to 50% survival rates with no device support). 

• Standing Office BP Readings: Data presented at the Hypertension 2022 meeting suggests that standing during blood pressure (BP) readings may lead to more accurate measurements and earlier hypertension diagnoses. Among 125 healthy adults, standing systolic BP showed superior sensitivity (43% vs. 74%) but inferior specificity (92% vs. 65%). The authors argue that high sensitivity is the more important metric when screening for common diseases such as hypertension.

• Philips’ Echo Workflow Solution: An expert panel study demonstrated that Philips’ Echo Workflow Solution supported efficiency, boosted diagnostic confidence, and improved patient and staff experiences. The authors surveyed seven experts from around the globe (via the Delphi method) and found that the experts unanimously agreed that the solution can enhance decision-making. The majority of respondents (86%) agreed that the Echo Workflow Solution can help increase confidence in diagnosis decision-making and can improve staff experience by providing single screen access to patient data. 

• CTAC AI CAC Scoring: A new JACC study highlighted a PET/CT attenuation correction (CTAC)-based AI model that can quickly (< 6 sec per scan) and accurately predict cardiovascular risk scores, without requiring different PET/CT protocols. The researchers trained the model using 9,543 ECG-gated CT scans and tested on ungated CTAC scans from 4,331 patients with major adverse cardiac events (MACE), finding that the deep learning CTAC solution’s negative predictive values for “MACE of zero” were similar to manual CAC scores (83% & 85%).

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