Background
Cardiac allograft vasculopathy (CAV) remains a major cause of morbidity and mortality among long-term heart transplant (HT) recipients. There is clearly an unmet need for a noninvasive biomarker of CAV that could obviate the need to perform surveillance coronary angiograms in these patients.
Purpose
Our aim was to evaluate the performance of Donor-derived Cell Free DNA (dd-cfDNA) as a biomarker of CAV.
Methods
We prospectively measured dd-cfDNA levels in all consecutive asymptomatic patients undergoing surveillance coronary angiography >1 year after HT at a single center, between Jan 2019 and Jan 2021. Endpoints included the association between dd-cfDNA levels and the presence CAV, according to ISHLT 2010 classification. Patients with history of acute cellular rejection ≥1R or antibody mediated rejection in the previous 6 months were excluded.
Results
We included 94 HT recipients, median age 57 years (IQR 50–67), 67% men, a median of 10.9 years after transplant. Coronary angiogram revealed CAV0, CAV1, CAV2 and CAV3 in 61%, 19%, 14% and 6% of patients, respectively. Median dd-cfDNA values for each CAV group were: CAV0 0.92% (IQR 0.46–2.0), CAV1 1.4% (0.38–2.8), CAV2 0.17% (0.07–0.52) and CAV3 0.24% (0.057–0.87); p=0.0535. Figure 1 summarizes baseline characteristics of the cohort and results.
Comparison of dd-cfDNA levels in patients with CAV0 and CAV1–2-3 did not show significant differences (0.92%, IQR 0.46–2.0 vs 0.46%, IQR 0.075–1.5, p=0.059) (Figure 2A), nor did the comparison between patients with stable CAV (no new coronary lesions since previous angiogram, n=77) and progressive CAV (patients with new coronary stenoses, n=17); median dd-cfDNA values were 0.735% (IQR 0.195–2.0) vs 0.9% (IQR 0.12–1.8), p=0.76 (Figure 2B). A subanalysis according to time after HT was also found non-significant: less than 5 years (p=0.95), 5 to 10 years (p=0.14) and more than 10 years after HT (p=0.16) (Figure 2C). The AUC ROC curve for the diagnosis of CAV revealed the lack of ability to predict the presence of any degree of CAV (AUC ROC = 0.38).
Conclusion
In our experience, dd-cfDNA did not perform as a useful biomarker to avoid surveillance coronary angiograms for CAV diagnosis.
FUNDunding Acknowledgement
Type of funding sources: Other. Main funding source(s): Sociedad Madrileña de Trasplantes
Background
The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares
peri
-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX.
Methods
Prospective, multicenter, “real-world” registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center’s prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared.
Results
359 patients [mean age 75.5 (SD8.1), CHA
2
DS
2
-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major
peri
-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed.
Conclusions
The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of
peri
-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted.
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