The Prevenzione Aterosclerosi Studio Torino (P.A.S.T.) was a prospective, randomized trial testing the effect on carotid and femoral atherosclerotic lesions of lipid-lowering therapy, as assessed by duplex scanning (DS) technique, in 85 patients (12 women, 73 men), forty-five to fifty-five years old, with ischemic heart disease (IHD), and randomly assigned to a hypolipidemic diet or diet + 250 mg acipimox (a nicotinic acid compound) two to three times/day. Forty-one patients, without inclusion criteria, were compared with the randomized groups as a reference population. All three groups were submitted to DS and to hematic monitoring of lipid levels at the beginning and at the end of the study. During three years of treatment, there was a significant reduction (-6.5%) in total plasma cholesterol in the diet + drug group (P = 0.04) and a simultaneous elevation of high-density lipoprotein cholesterol, significant in the treatment groups (respectively, +15% P = 0.02 in the diet and +16% P = 0.016 in the diet + drug group). Every group showed a trend toward the increasing number of lesions in all explored areas and toward the progression in size of the already existing ones. Whereas in the initial DS the prevalence of lesions was significantly lower in the nonrandomized group in every site, at the end of the study the total number of lesions did not differ among groups, and there was a significant increase of plaques in carotid area in the nonrandomized group in comparison with the treatment groups. The final number of stable plaques was greater in the treatment groups as compared with the nonrandomized group (P = 0.01 diet vs nonrandomized, P = 0.03 diet + drug vs nonrandomized). In conclusion, lipid-lowering treatment, with diet and with diet + drug, was useful in slowing the natural progression of atherosclerosis; particularly, it reduced the development of new lesions in the carotid and femoral arteries and increased the stability of the already existing ones. In these patients, diet was equivalent to diet + drug in regard to progression of lesions. The most favorable results in the treatment groups seem to correlate with high-density lipoprotein cholesterol, significantly increased in comparison with the nonrandomized group.
Aims
Permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI) has emerged as a relevant issue, being more frequent than after surgery and the progressive shift towards low-risk patients stressed the importance to reduce the risk of complications that could impact patient’s long-term prognosis. Long-term right ventricular pacing has been related to an increased risk of electromechanical asynchrony, negative left-ventricular remodelling, atrial fibrillation and heart failure, but there is a lack of evidence regarding the prognostic impact on TAVI patients. The aim of this international multicentre study is to assess the impact of right ventricular pacing on prognosis of TAVI patients undergone pacemaker implantation after the procedure due to conduction disorders.
Methods and results
All the consecutive patients with severe aortic stenosis treated with TAVI and subsequently underwent pacemaker implantation in each participating centre were enrolled. Patients were divided into two subgroups according to the percentage of ventricular pacing (VP cut-off: 40%) at pacemaker interrogation. The primary endpoint was the composite of cardiovascular mortality and hospitalization for heart failure in subgroups based on the percentage of ventricular stimulation. All cause and cardiovascular mortality in the subgroups according to the percentage of ventricular pacing were the secondary endpoints. In total, 427 patients were enrolled, 153 patients with VP < 40% and 274 with a with VP ≥ 40%. Patients with VP ≥ 40% were older (81.16 ± 6.4 years vs. 80.51 ± 6.8 years), with higher NYHA class, a lower EF (55.26 ± 12.2 vs. 57.99 ± 11.3 P = 0.03), an increased end diastolic ventricular volume (112.11 ± 47.6 vs. 96.60 ± 40.4, P = 0.005) and diameter (48.89 ± 9.7 vs. 45.84 ± 7.5 P = 0.01). A higher incidence of moderate post-procedural paravalvular leak was observed in patients with VP ≥ 40% (37.5% vs. 26.85%, P = 0.03). Ventricular pacing ≥40% was associated with a higher incidence of the composite primary endpoint of CV mortality and HF hospitalization (p at log rank test = 0.006, adjusted HR: 2.41; 95% CI: 1.03–5.6; P = 0.04). Patients with ventricular pacing ≥ 40% had also a higher risk of all-cause (p at log rank test = 0.03, adjusted HR = 1.57; 95% CI: 1.03–2.38; P = 0.03) and cardiovascular (p at log ank test =0.008, adjusted HR: 3.77; CI: 1.32–10.78; P = 0.006) mortality compared to patients with a VP < 40%.
Conclusions
TAVI Patients underwent permanent pacemaker implantation after the procedure due to conduction disorders and with a VP ≥ 40% at follow-up are at increased risk of cardiovascular death and HF hospitalizations and of all-cause mortality compared to patients with a VP < 40%. It is mandatory to reduce the percentage of ventricular pacing at follow-up when possible or consider left ventricular branch pacing and biventricular pacing in TAVI patients.
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