A multicenter evaluation of the HeartMate 3 risk score.

BACKGROUND: The Heartmate 3 (HM3) risk score (HM3RS) was derived and validated internally from within the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) trial population and provides 1- and 2-year mortality risk prediction for patients in those before HM3 left ventricular assist device (LVAD) implantation. We aimed to evaluate the HM3RS in nontrial unselected patients, including those not meeting inclusion criteria for MOMENTUM 3 trial enrollment. METHODS: Patients who underwent HM3 LVAD implant at 1 of 7 US centers between 2017 and 2021, with at least 1-year follow-up, were included in this analysis. Patients were retrospectively assessed for their eligibility for the MOMENTUM 3 trial based on study inclusion and exclusion criteria. HM3RS risk discrimination was evaluated using time-dependent receiver operating characteristic curve analysis for 1-year mortality for all patients and further stratified by MOMENTUM 3 trial eligibility. Kaplan-Meier curves were constructed using the HM3RS-based risk categories. RESULTS: Of 521 patients included in the analysis, 266 (51.1%) would have met enrollment criteria for MOMENTUM 3. The 1- and 2-year survival for the total cohort was 85% and 81%, respectively. There was no statistically significant difference in survival between those who met and did not meet enrollment criteria at 1 (87% vs 83%; p = 0.21) and 2 years postimplant (80% vs 78%; p = 0.39). For the total cohort, HM3RS predicted 1-year survival with an area under the curve (AUC) of 0.63 (95% confidence interval [CI]: 0.57-0.69, p < 0.001). HM3RS performed better in the subset of patients meeting enrollment criteria: AUC 0.69 (95% CI:0.61-0.77, p < 0.001) compared to the subset that did not: AUC 0.58 (95% CI: 0.49-0.66, p = 0.078). CONCLUSIONS: In this real-world evidence, multicenter cohort, 1- and 2-year survival after commercial HM3 LVAD implant was excellent, regardless of trial eligibility. The HM3RS provided adequate risk discrimination in "trial-like" patients, but predictive value was reduced in patients who did not meet trial criteria.

The prognostic and diagnostic implications of surveillance serial myocardial perfusion imaging in asymptomatic renal transplant candidates.

BACKGROUND: The utility of serial SPECT myocardial perfusion imaging (MPI) for CAD surveillance in asymptomatic ESRD patients awaiting kidney transplantation (KT) is uncertain. METHODS AND RESULTS: We retrospectively investigated 700 asymptomatic KT candidates with ≥ 2 pre-transplant SPECT-MPIs (mean interval, 20 ± 13 months). Worsening MPI was defined as total perfusion deficit increase (ΔTPD) > 5%. High clinical risk was defined as ≥ 3 AHA/ACC KT risk factors. The primary outcome was major adverse cardiac events (MACE) of cardiac death or myocardial infarction. The initial MPI was normal in 462 (66%) subjects. On repeat MPI, ΔTPD > 5% was observed in 82 (12%) subjects, and the incidence increased with increasing time gap between MPIs (P = .006). During a mean follow-up of 16 ± 8 months, there were 119 (17%) MACEs. In the entire cohort, ΔTPD > 5% was not significantly associated with MACE (HR = 1.38; P = .210). ΔTPD > 5% was associated with increased MACE rate among patients with normal initial MPI (HR = 2.30; P = .005), but not among those with abnormal initial MPI (P = .260). There was a significant interaction between ΔTPD > 5% and initial MPI normalcy status in predicting MACE (interaction P = .018), such that the predictive value of ΔTPD is dependent on the initial MPI normalcy. Among subjects with normal initial MPI, ΔTPD > 5% was significantly associated with MACE only if the sum of KT risk factors was ≥ 3 (HR = 2.26; P = .016). Among 123 patients who underwent coronary angiography, ΔTPD > 5% was associated with a higher prevalence of obstructive CAD when the initial MPI was normal and the sum of KT risk factors was ≥ 3. CONCLUSION: Among patients with ESRD waitlisted for KT, new/worsening MPI abnormalities are expected. On serial surveillance, ΔTPD > 5% is associated with MACE and obstructive CAD among those with a normal initial MPI and ≥ 3 AHA/ACC KT risk factors.

Outcomes with drug-coated balloons in small-vessel coronary artery disease.

BACKGROUND: Percutaneous coronary intervention (PCI) of small-vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug-coated balloons (DCBs) in SVD has received limited study. OBJECTIVES: To assess the outcomes of DCB in the treatment of SVD compared with the standard of care. METHODS: We performed a meta-analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD. RESULTS: Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow-up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug-eluting stents (DES). During a mean follow-up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04-0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08-0.37, P = <0.00001) compared with noncoated balloon angioplasty. CONCLUSION: The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.

Outcomes With Drug-Coated Balloons for Treating the Side Branch of Coronary Bifurcation Lesions.

BACKGROUND: Treating coronary bifurcations remains limited by technical difficulties and suboptimal long-term outcomes, often affecting the side branch (SB). Drug-coated balloon (DCB) in SB treatment could reduce neointimal hyperplasia and the risk for restenosis. METHODS: We performed a systematic review of all studies published between January 2000 and February 2018 reporting the outcomes of DCB vs non-coated balloon angioplasty (BA) in the treatment of the SB in coronary bifurcation lesions. Outcomes included SB late lumen loss, SB binary restenosis, target-lesion revascularization (TLR), and major adverse cardiac event (MACE) rate. RESULTS: Four studies with 349 patients were included in the meta-analysis (three randomized controlled trials [RCTs] and one observational study). SB stenting was performed in 7.5% vs 8.6% in the DCB and BA groups, respectively. Angiographic follow-up performed after a mean follow-up of 9.1 ± 2.1 months demonstrated that DCB was associated with lower SB late lumen loss compared with BA (mean difference, -0.19 mm; 95% confidence interval [CI], -0.37 to -0.01; P=.04). There was no difference in the risk of SB binary restenosis (odds ratio [OR], 0.52; 95% CI, 0.18-1.47; P=.22). During a mean follow-up of 15.1 ± 5.8 months, DCB and BA had similar risk of MACE (OR, 0.76; 95% CI, 0.4-1.4; P=.40), and TLR (OR, 0.85; 95% CI, 0.3-2.4; P=.76). CONCLUSION: Assessment of DCB for SB treatment of coronary bifurcations is limited by low power due to the small number of patients studied. Use of DCB was associated with lower SB late lumen loss, but this did not translate into improved clinical outcomes.