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Page 4 of 9 Benito-González et al. Mini-invasive Surg 2020;4:67 I http://dx.doi.org/10.20517/2574-1225.2020.54

Table 1. Baseline characteristics of patients included in the study cohort
All patients (n = 70) Frail (n = 27) Non frail (n = 43) P value
Age (years) 75.3 ± 9.9 77.8 ± 9.0 73.7 ± 10.2 0.043
Male (%) 65.7 66.7 65.1 0.894
2
Body mass index (kg/m ) 27.2 ± 5.5 25.6 ± 4.3 28.2 ± 6.0 0.030
Serum albumin < 4 g/dL (%) 44.3 59.3 34.9 0.046
Smoking (%) 40.0 44.4 37.2 0.548
Hypertension (%) 65.7 77.8 58.1 0.092
Diabetes (%) 27.1 25.9 27.9 0.856
Chronic obstructive pulmonary disease (%) 30.0 40.7 23.3 0.120
Glomerular filtrate rate ≤ 60 mL/min (%) 47.1 59.3 39.5 0.108
Peripheral arteriopathy (%) 22.9 29.6 18.6 0.285
Stroke (%) 14.3 18.5 11.6 0.493
Cognitive impairment (%) 7.1 14.8 2.3 0.069
Anemia (%) 44.3 59.3 34.9 0.046
Ischemic cardiopathy (%) 48.6 48.2 48.8 0.955
Acute myocardial infarction 31.4 37.0 27.9 0.423
Coronary revascularization 40.0 40.7 39.5 0.920
Percutaneous coronary intervention 34.3 33.3 34.9 0.894
Coronary artery bypass grafting 14.3 18.5 11.6 0.423
Non-coronary cardiac surgery (%) 14.3 11.1 16.3 0.730
Implantable cardiac device (%) 31.4 22.2 37.2 0.189
Atrial fibrillation (%) 62.9 66.7 60.5 0.601
Left ventricular ejection fraction (%) 40.5 ± 16.3 41.1 ± 16.9 40.1 ± 16.1 0.597
Mitral regurgitation (%) 1.0
3+ 10.0 11.1 9.3
4+ 90.0 88.9 90.7
Etiology of mitral regurgitation (%) 0.298
Degenerative o mixed 27.1 33.3 23.3
Ischemic functional 35.7 40.7 32.6
Non-ischemic 37.1 25.9 44.2
Severe pulmonary hypertension (%) 22.9 29.6 18.6 0.285
Prior heart failure admission within 12 months 1 [1-2] 2 [1-3] 1 [1-2] 0.044
NYHA functional class (%) 0.104
II 18.6 14.8 20.9
III 67.1 59.3 72.1
IV 14.3 25.9 7.0
NT-pro brain natriuretic peptide (pg/mL) 2030.5 [1126.0- 2962.0 [1525.0- 2030.5 [1126.0- 0.070
3428.0] 9059.0] 3428.0]
Euro score logistic (%) 17.4 [10.1-30.3] 21.6 [11.1-36.9] 16.0 [9.2-29.2] 0.151
Society of thoracic surgeons (%) 3.6 [1.9-5.4] 4.2 [2.4-6.1] 2.8 [1.2-5.4] 0.060
Seattle heart failure risk score (%) 16.6 [10.5-20.3] 19.8 [14.0-30.6] 15.4 [8.4-19.5] 0.005

NYHA: New York Heart Association

apparatus with massive residual MR after MitraClip® deployment. Overall, procedural technical success
was 98.6%, with no differences between the two groups (P = 1.0). Likewise, no significant differences in the
incidence of major procedural complications were observed during hospitalization.

At 30-day echocardiographic follow-up, one patient (1.4%) had partial clip detachment with severe residual
MR, and 6 patients (8.6%) had residual MR > 2+ and/or transmitral mean gradient ≥ 5 mmHg. One patient
with very severe left ventricular dysfunction died within 30 days after discharge. Overall, device success
rate at 30 days was 84.3%, with no differences between frail and non-frail groups (P = 0.739).

Clinical outcomes
At 6-month follow up, both groups of patients showed a significant improvement in NYHA functional class
(frail: P = 0.002; non-frail: P < 0.001; Figure 1). During a median follow-up of 675 days (range 416-976),
22 patients (31.4%) were hospitalized due to HF and 16 patients (22.9%) died. The composite endpoint of
readmission for HF or death from any cause occurred in 30 patients (42.9%).