Background
In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of ...systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double‐blind randomized pilot study.
Methods and Results
Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual‐chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1‐month run‐in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between‐group difference of the change in 24‐hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, −15.2 to −8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (−7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (−14.2 to −1.9 mm Hg) (
P
=0.012). There were no Moderato device– or CNT‐related adverse events.
Conclusions
CNT significantly reduced 24‐hour aSBP in patients with hypertension with a clinical indication for a pacemaker. The majority of patients had isolated systolic hypertension, a particularly difficult group of patients to treat.
Registration
URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02837445.
The cardiac resynchronisation therapy (CRT) survey II is a joint initiative between the European Heart Rhythm Association and the Heart Failure Association. It compiles real world data about cardiac ...resynchronisation therapy in European Society of Cardiology member states. 11 088 patients assigned to implantation of CRT with pacemaker function (CRT-P) or CRT with an incorporated defibrillator (CRT-D) were enrolled in the survey starting 1 October 2015 till 31 December 2016 and for each patient, an electronic case report form (eCRF) was completed. Each participating country had each eCRF data-point benchmarked against the total cohort. In total, 79 patients were included from Latvia. The mean age of patients was 68.1, similar to the total cohort of other ESC member states, and 21.8% of patients were female. Latvian patients compared to other countries more often had permanent atrial fibrillation, NYHA class III and IV, ejection fraction 35 %. CRT-Ds and multipolar lead implantation rates were higher. Peri-procedural complication rates were similarly low in both groups. At discharge, prescribed medication rates were similar but more frequently MRAs, ivabradine and calcium channel blockers were prescribed and slightly less frequently ACE inhibitors/ARBs were prescribed. The CRT survey II is a valuable resource that describes ongoing practice of cardiac resynchronisation therapy around Europe and benchmarking against the total cohort is nationally significant for each participating country.
The indications for conservative "best medical treatment" (BMT) versus additional renal artery stenting are a matter of ongoing debate. The RADAR study aimed to evaluate the impact of percutaneous ...renal artery stenting on the impaired renal function in patients with hemodynamically significant atherosclerotic renal artery stenosis (RAS).
RADAR is an international, prospective, randomized (1:1) controlled study comparing BMT alone versus BMT plus renal artery stenting in patients with duplex sonographic hemodynamically relevant RAS. Follow-up assessments were at 2, 6, and 12 months and at 3 years. The primary endpoint was change in estimated glomerular filtration rate (eGFR) at 12 months.
Due to slow enrollment, RADAR was terminated early after inclusion of 86 of the scheduled 300 patients (28.7%). Change in eGFR between baseline and 12 months was 4.3 ± 15.4 ml/min/1.73 m
(stent group) and 3.0 ± 14.9 ml/min/1.73 m
(BMT group), p > 0.999. Clinical event rates were low with a 12-month composite of cardiac death, stroke, myocardial infarction, and hospitalization for congestive heart failure of 2.9% in the stent and 5.3% in the BMT group, p = 0.526, and a 3-year composite of 14.8% and 12.0%, p = 0.982. At 3 years, target vessel (re-)vascularization occurred in one patient (3.0%) in the stent group and in 8 patients (29.4%) in the BMT group.
In RADAR, outcomes of renal artery stenting were similar to BMT. These results have to be interpreted with the caveat that the study did not reach its statistically based sample size.
Clinicaltrials.gov, NCT00640406. Registered on 17 March 2008.
Abstract Objectives The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the ...treatment of de novo coronary artery lesions. Background Polyzene-F–coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. Methods Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. Results Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. Conclusions The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.
BackgroundIt is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) ...or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.MethodsThe study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.ResultsA total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI −0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.ConclusionIn the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.Trial registration numberNCT01496638.
To assess the impact of the COVID-19 pandemic on admissions of patients with acute coronary syndromes (ACS) and primary percutaneous coronary intervention (PPCI) in countries participating in the ...Stent-Save a Life (SSL) global initiative.
We conducted a multicenter observational survey to collect data on patient admissions for ACS, ST-elevation myocardial infarction (STEMI) and PPCI in participating SSL member countries through a period during the COVID-19 outbreak (March and April 2020) compared with the equivalent period in 2019. Of the 32 member countries of the SSL global initiative, 17 agreed to participate in the survey (three in Africa, five in Asia, six in Europe and three in Latin America). Overall reductions of 27.5% and 20.0% were observed in admissions for ACS and STEMI, respectively. The decrease in PPCI was 26.7%. This trend was observed in all except two countries. In these two, the pandemic peaked later than in the other countries.
This survey shows that the COVID-19 outbreak was associated with a significant reduction in hospital admissions for ACS and STEMI as well as a reduction in PPCI, which can be explained by both patient- and system-related factors.
Avaliar o impacto da pandemia COVID-19 nas admissões de doentes com síndromes coronárias agudas (SCA) e angioplastia coronária primária (PPCI) em países que participam da iniciativa global Stent-Save a Life (SSL).
Realizámos estudo observacional multicêntrico para coletar dados sobre admissões de doentes por ACS, STEMI e PPCI nos países participantes no SSL durante um período do surto COVID-19 (março e abril de 2020) em comparação com o período homólogo de 2019. Dos 32 países membros da iniciativa global SSL, 17 aceitaram participar no estudo (3 de África, 5 da Ásia, 6 da Europa e 3 da América Latina (LATAM)). Observámos uma redução global de 27,5% e 20,0% nos internamentos com SCA e STEMI, respetivamente. A diminuição do PPCI foi de 26,7%. Essa tendência foi observada em todos os países, exceto dois. Nestes dois países, a pandemia atingiu o pico mais tarde do que nos restantes.
Este estudo mostra que o surto de COVID-19 foi associado a uma redução significativa de admissões hospitalares por SCA e STEMI, bem como uma redução de PPCI, o que pode ser explicado por fatores relacionados com o doente e com o sistema.
There is limited data on the genetic characteristics of patients with familial hypercholesterolemia (FH) in Latvia. We aim to describe monogenic variants in patients from the Latvian Registry of FH ...(LRFH).
Whole genome sequencing with 30× coverage was performed in unrelated index cases from the LRFH and the Genome Database of Latvian Population.
,
,
,
,
,
,
,
,
, and
genes were analyzed. Only variants annotated as pathogenic (P) or likely pathogenic (LP) using the FH Variant Curation Expert Panel guidelines for
and adaptations for
and
were reported.
Among 163 patients, the mean highest documented LDL-cholesterol level was 7.47 ± 1.60 mmol/L, and 79.1% of patients had LDL-cholesterol ≥6.50 mmol/L. A total of 15 P/LP variants were found in 34 patients (diagnostic yield: 20.9%): 14 in the
gene and 1 in the
gene. Additionally, 24, 54, and 13 VUS were detected in
and
, respectively. No P/LP variants were identified in the other tested genes.
Despite the high clinical likelihood of FH, confirmed P/LP variants were detected in only 20.9% of patients in the Latvian cohort when assessed with genome-wide next generation sequencing.
Abstract
Coronary artery chronic total occlusions (CTO) are common — approximately one-third of patients with significant coronary artery disease on angiography have at least 1 CTO. Invasive ...treatment of these lesions still remain a major challenge for interventional cardiology due to their complexity. Historically, success rates have improved to about 60–70% by using only the traditional antegrade approach. The results have dramatically improved during the last decade after more widespread application of new retrograde techniques. The aim of our study was to review and analyse single hospital experience in CTO invasive treatment and to evaluate the long-term results. A total of 519 patients undergoing percutaneous coronary interventions (PCI) for CTO at a single tertiary PCI centre (Rīga East University Hospital), were included in the study. The median age was 64 years (38–88), and 80% were male. The retrograde approach (RA) was used for 167 (32.2%) of the CTO PCI patients. The overall patient success rate was 81.3% and it increased from 73.9% in 2007 to 95.2% in 2015 (
p
< 0.001). Mean patient observation time was five years. Overall survival was found significantly better in patients group after successful CTO PCI procedures (Long-rank test,
p
= 0.013).
Abstract Background The COMBO stent is a novel sirolimus-eluting stent with a luminal anti-CD34 + antibody layer to promote vessel healing. No data is currently available on clinical outcomes after ...treatment with this novel bio-engineered device in diabetic patients. We evaluate clinical outcomes at twelve months after COMBO stent placement in patients without diabetes mellitus (non-DM), patients with non-insulin-treated diabetes mellitus (nITDM) and patients with insulin-treated diabetes mellitus (ITDM). Methods This study is a pre-specified subgroup analysis of the 1000 patient all-comers REMEDEE Registry. The primary endpoint is target lesion failure (TLF), which is a combined endpoint consisting of cardiac death, target vessel-myocardial infarction (tv-MI) and target lesion revascularization (TLR) at twelve months follow-up. Kaplan Meier method is used with log rank to compare outcomes between groups. Results This subgroup analysis includes 807 non-DM, 117 nITDM and 67 ITDM. Kaplan–Meier estimates for TLF at twelve months are 4.4% in non-DM, 6.8% in nITDM and 20.3% in ITDM, p < 0.001 (non-DM vs nITDM p = 0.244, non-DM vs ITDM p < 0.001). Conclusions This study gives the first insight into the impact of insulin-treated diabetes mellitus on clinical outcome of patients treated with the novel COMBO stent. At one year after COMBO stent placement significantly higher rates of target lesion failure are seen in patients with ITDM compared to patients with nITDM and patients without DM.
OBJECTIVESHelicobacter pylori infection and atrophic gastritis are related to an increased risk for gastric cancer. There is a decrease in global H. pylori prevalence. We analyzed the prevalence of ...H. pylori infection in Latvia by the plasma IgG test and the presence of atrophy by means of pepsinogen testing.
METHODSThis subanalysis was carried out on a randomly selected cross-sectional sample of a general population of adults to access cardiovascular risk factors. Plasma samples were screened for H. pylori IgG (cutoff value 24 U/ml), and pepsinogens (Pg) I and II. Pg cutoff values of PgI/PgII≤3 and PgI≤70 ng/ml were used to assess the prevalence of atrophy of any grade and PgI/PgII≤2 and PgI≤30 ng/ml for advanced atrophy.
RESULTSAltogether, 3564 serum samples were available for the study (2346 women, 1218 men; median age 54 years). Of the tested individuals, 79.21% were H. pylori positive, with no difference between sexes. The prevalence increased with age (P<0.001). Atrophy of any grade was identified in 1444 individuals (40.52%) and advanced atrophy in 475 individuals (13.33%). Linear association with age was present in both response types (P<0.001). The prevalence of atrophy of any grade was higher in women (41.73%) than in men (38.18%; P=0.04); this difference was lost for advanced atrophy (women 13.98%, men 12.07%; P=0.1).
CONCLUSIONThe prevalence of H. pylori infection or atrophy remains high in Latvia. Determining the right cutoff value is critically important for pepsinogen-based atrophy detection in Europe in order to objectively stratify gastric cancer risk.
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