Daily Cardiology Research Analysis
Three high-impact cardiology studies advance long-term TAVR management and preventive pharmacotherapy. A large Japanese registry shows even mild paravalvular regurgitation after TAVR increases bioprosthetic valve failure and mortality over up to 9 years, while a Bern registry links real-time fluoroscopic underexpansion to mid-term hemodynamic valve deterioration. Separately, SGLT2 inhibitors are associated with markedly lower mortality and heart failure hospitalizations in pacemaker recipients.
Summary
Three high-impact cardiology studies advance long-term TAVR management and preventive pharmacotherapy. A large Japanese registry shows even mild paravalvular regurgitation after TAVR increases bioprosthetic valve failure and mortality over up to 9 years, while a Bern registry links real-time fluoroscopic underexpansion to mid-term hemodynamic valve deterioration. Separately, SGLT2 inhibitors are associated with markedly lower mortality and heart failure hospitalizations in pacemaker recipients.
Research Themes
- Long-term durability and surveillance after TAVR
- Procedural imaging metrics predicting valve performance
- Cardiometabolic therapy benefits in device-implanted populations
Selected Articles
1. Long-Term Impact of Mild Paravalvular Regurgitation After Transcatheter Aortic Valve Replacement: The OCEAN-TAVI Registry.
In 5,068 TAVR patients with no/trace or mild PVR at discharge, mild PVR independently predicted higher long-term bioprosthetic valve failure and all-cause mortality over up to 9 years. Risks were particularly elevated with balloon-expandable valves, nontransfemoral access, and severe renal dysfunction.
Impact: This is the largest long-term analysis linking even mild PVR to valve failure and mortality, reframing ‘mild’ as clinically meaningful. It supports procedural strategies and surveillance to minimize PVR.
Clinical Implications: Aim for meticulous valve sizing, positioning, and post-dilation to minimize PVR. Implement structured follow-up to detect early hemodynamic deterioration, prioritizing patients with balloon-expandable valves, nontransfemoral access, and severe CKD.
Key Findings
- Mild PVR occurred in 31.6% and increased 9-year all-cause mortality (75.9% vs 72.2%; log-rank P=0.014).
- Mild PVR independently predicted BVF (sHR 1.48; 95% CI 1.07-2.04) and all-cause mortality (HR 1.11; 95% CI 1.02-1.21).
- Risk of BVF was higher with balloon-expandable valves (sHR 1.46), nontransfemoral TAVR (sHR 5.58), and eGFR <30 mL/min/1.73 m2.
Methodological Strengths
- Large prospective registry with long follow-up (median 4.7 years; up to 9 years)
- Standardized VARC-3 outcomes and appropriate competing risk (Fine-Gray) and Cox modeling
Limitations
- Observational design with potential residual confounding
- PVR assessment at discharge may not capture dynamic changes over time; imaging core lab details not specified
Future Directions: Prospective trials of procedural optimization and device iterations targeting PVR reduction, and risk-adapted surveillance algorithms to prevent BVF.
BACKGROUND: The clinical significance of mild paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR) remains uncertain. OBJECTIVES: The aim of this study was to evaluate the impact of mild PVR on long-term clinical outcomes and bioprosthetic valve failure (BVF) following TAVR. METHODS: A total of 5,068 patients from the OCEAN-TAVI (Optimized Catheter Valvular Intervention-Transcatheter Aortic Valve Implantation) registry (UMIN000020423) who underwent TAVR and had no or trace or mild PVR at discharge were analyzed. Patients were stratified according to PVR severity and followed for up to 9 years. The primary outcomes were all-cause mortality and BVF, defined according to Valve Academic Research Consortium 3 criteria. RESULTS: Median follow-up duration was 4.7 years (Q1-Q3: 2.9-6.0 years). Mild PVR was observed in 1,601 patients (31.6%). At 9-year follow-up, Kaplan-Meier analysis demonstrated a significantly higher cumulative incidence of all-cause mortality (75.9% [95% CI: 71.3%-80.2%] vs 72.2% [95% CI: 68.1%-76.3%]; log-rank P = 0.014) and BVF (20.7% [95% CI: 12.8%-32.5%] vs 17.3% [95% CI: 11.0%-26.6%]; P = 0.029) in patients with mild PVR than in those with no or trace PVR. Fine-Gray analysis confirmed mild PVR as an independent predictor of BVF (subdistribution HR [sHR]: 1.48; 95% CI: 1.07-2.04; P = 0.018), and Cox regression showed a significant association with all-cause mortality (HR: 1.11; 95% CI: 1.02-1.21; P = 0.014). The risk for BVF was especially elevated in patients receiving balloon-expandable valves (sHR: 1.46; 95% CI: 1.02-2.08; P = 0.038), those undergoing nontransfemoral TAVR (sHR: 5.58; 95% CI: 1.57-19.9; P = 0.0086), and those with impaired renal function (estimated glomerular filtration rate < 30 mL/min/1.73 m CONCLUSIONS: Mild PVR after TAVR is associated with a significantly increased risk for BVF and all-cause mortality, highlighting the importance of optimizing valve deployment and monitoring patients with even mild PVR.
2. Favorable outcomes of SGLT2 inhibitor use in pacemaker recipients: a population-based study.
In 11,518 pacemaker recipients, propensity score–matched analyses showed SGLT2 inhibitor therapy was associated with a 38% lower all-cause mortality and a 50% lower heart failure hospitalization over 3 years. Benefits were consistent across subgroups.
Impact: This study extends the cardioprotective profile of SGLT2 inhibitors to a high-risk, device-implanted population with limited prior evidence. It suggests a preventive role beyond established heart failure indications.
Clinical Implications: Consider SGLT2 inhibitors after pacemaker implantation in appropriate patients to reduce HF admissions and mortality, while awaiting prospective randomized validation.
Key Findings
- After matching (n=1,226 per group), SGLT2i use was associated with lower all-cause mortality (HR 0.62; 95% CI 0.50–0.78).
- HF hospitalization was reduced by half with SGLT2i (HR 0.50; 95% CI 0.41–0.62).
- Effects were consistent across prespecified subgroups.
Methodological Strengths
- Large population-based cohort with robust propensity score matching
- Consistent effect estimates across subgroups enhance external validity
Limitations
- Retrospective observational design susceptible to residual confounding and indication bias
- Medication adherence, dose, and changes over time not fully captured
Future Directions: Randomized controlled trials in pacemaker recipients to confirm causality and define optimal timing, dosing, and patient selection for SGLT2 inhibitors.
BACKGROUND: Pacemaker recipients are predisposed to heart failure (HF), yet evidence guiding preventive pharmacotherapy in this population remains unexplored. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have redefined HF management across a broad spectrum of cardiometabolic phenotypes. This study evaluated the association between SGLT2i therapy and clinical outcomes after pacemaker implantation for atrioventricular block. METHODS: Patients receiving conventional pacemakers between 2016 and 2024 were retrospectively analyzed and stratified by baseline SGLT2i therapy. Exclusions included sinus node dysfunction or iatrogenic pacing indications, single-chamber devices, and estimated glomerular filtration rate < 20 mL/min/1.73m RESULTS: Among 11,518 eligible patients, propensity score matching yielded two well-balanced cohorts of 1,226 SGLT2i users and non-SGLT2i users. Over three years, death occurred in 124 (10.1%) in the SGLT2i users and in 194 (15.8%) in the non-SGLT2i group (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.50 to 0.78; P < 0.001). HF hospitalization occurred in 132 (10.7%) in the SGLT2i group, and in 280 (22.8%) in the non-SGLT2i group (HR, 0.50; 95% CI, 0.41 to 0.62; P < 0.001). Subgroup analyses demonstrated consistent effects across strata. CONCLUSIONS: SGLT2i therapy was associated with reduced risk of all-cause mortality and HF-related hospitalizations following pacemaker implantation. Future randomized studies are needed to confirm this association.
3. Real-Time Fluoroscopic Assessment of Underexpansion Predicts Hemodynamic Valve Deterioration Following TAVR With Balloon-Expandable Device.
In 1,043 balloon-expandable TAVR recipients, real-time fluoroscopic underexpansion ≥20% predicted a nearly fivefold increase in 5-year hemodynamic valve deterioration. The risk rose incrementally with each 5% underexpansion and was not associated with mortality at a median of 862 days.
Impact: This study operationalizes an intra-procedural, validated fluoroscopic metric to predict adverse valve hemodynamics, enabling real-time mitigation strategies during TAVR.
Clinical Implications: Intra-procedural quantification of underexpansion can guide post-dilation and device selection, especially in high calcium burden or bicuspid anatomy, to reduce mid-term valve deterioration.
Key Findings
- Underexpansion ≥20% occurred in 5.4% and increased 5-year HVD risk (sHR 4.88; 95% CI 2.18–10.97).
- HVD risk increased progressively with underexpansion (sHR 1.94 per 5% increment; 95% CI 1.42–2.79).
- Predictors of underexpansion: larger aortic valve calcium volume, bicuspid anatomy, and valve iteration; no mortality association at median 862 days.
Methodological Strengths
- Validated fluoroscopic measurement method with objective thresholding
- Competing risk models and dose–response analysis across valve sizes
Limitations
- Retrospective analysis of a prospective registry; potential selection and imaging variability
- Generalizability limited to balloon-expandable devices and a single national registry
Future Directions: Prospective studies to test underexpansion-guided optimization (post-dilation strategies, device iteration) and integration into procedural checklists.
BACKGROUND: The clinical sequelae of transcatheter heart valve (THV) underexpansion following transcatheter aortic valve replacement (TAVR) with balloon-expandable devices remain incompletely understood. OBJECTIVES: The aim of this study was to investigate the impact of THV underexpansion on clinical outcomes among patients treated with balloon-expandable TAVR. METHODS: Consecutive patients undergoing transfemoral TAVR with the SAPIEN 3 and SAPIEN 3 Ultra systems in the prospective Bern TAVI registry were retrospectively evaluated. THV underexpansion was assessed on postimplantation fluoroscopic images and quantified using the validated commissural post height method. Significant THV underexpansion was defined as a reduction in stent frame midportion diameter ≥20% compared with the nominal diameter, using an optimal cutoff value determined by maximizing the log-rank statistic. The outcomes of interest were moderate or severe hemodynamic valve deterioration (HVD) according to the Valve Academic Research Consortium 3 and all-cause and cardiovascular mortality at 5-year follow-up. RESULTS: Among 1,043 patients (median age 81 years; Q1-Q3: 76-85 years; 34.6% women) undergoing TAVR with SAPIEN 3 or SAPIEN 3 Ultra valves between 2014 and 2022, 57 (5.4%) exhibited THV underexpansion. THV underexpansion ≥ 20% was associated with an increased risk for HVD at 5-year follow-up (subdistribution HR: 4.88; 95% CI: 2.18-10.97). The risk for HVD gradually increased with increasing degree of underexpansion (subdistribution HR: 1.94 per 5% increase; 95% CI: 1.42-2.79), with consistent findings across all valve sizes. Total aortic valve calcium volume, bicuspid anatomy, and valve iteration were significant predictors of THV underexpansion. At 862-day follow-up (Q1-Q3: 366-1,812 days), underexpansion was not associated with mortality. CONCLUSIONS: Underexpansion of balloon-expandable THVs is associated with an increased risk for HVD at mid-term follow-up.