Coronary sinus Reducer device for the treatment of refractory angina: A multicenter initial experience
Bibliographic record
Abstract
The coronary sinus Reducer (CSR) device has emerged as a complementary therapy in patients with severe angina refractory to optimal medical therapy and not amenable to revascularization. Our aim was to assess the safety and efficacy of the CSR in a real-world setting. Twenty-six patients with refractory angina (RA) and evidence of myocardial ischemia attributable to the left coronary artery considered unsuitable for revascularization were treated with the CSR at two centers between May 2017 and July 2019. Safety endpoints were procedural success and complications. Efficacy endpoints, assessed at six-month follow-up, were reduction in CCS class, improvement in quality of life (QoL) assessed using the short version of the Seattle Angina Questionnaire (SAQ-7), and reduction in antianginal therapy. Twenty-three patients had end-stage coronary artery disease without revascularization targets and three had microvascular disease without epicardial stenosis. Procedural success was achieved in 23 patients, with two device/procedure-related complications and one anatomically-related failure to deliver the device. A total of 24 patients had the device implanted and entered the efficacy analysis. Eighteen patients (75.0%) had a reduction of at least one CCS class, 41.7% had a reduction of at least two classes, and 16.7% became asymptomatic, with a mean reduction in CCS class of 1.3±0.2 (p=0.001) at six-month follow-up. All SAQ-7 domains improved, notably physical limitation (p=0.001), angina frequency (p=0.005) and QoL (p=0.006). There was a mean reduction in anti-ischemic drugs from 3.4±1.1 to 2.9±1.2 (p=0.010). In this real-world, multicenter experience, implantation of the CSR was associated with improvement in angina and QoL in patients with RA. O dispositivo de redução do seio coronário (DRSC) constitui uma terapêutica complementar em doentes com angina refratária à terapêutica médica e não passíveis de revascularização. O objectivo era avaliar a segurança e eficácia do DRSC numa coorte do mundo real. Vinte e seis doentes com angina refratária, evidência de isquemia miocárdica atribuível à artéria coronária esquerda e considerados inadequados para revascularização foram tratados com o DRSC em dois centros terciários portugueses entre maio de 2017 e julho de 2019. Os endpoints de segurança foram o sucesso do procedimento e complicações. Os endpoints de eficácia, avaliados aos seis meses de follow-up, foram uma redução na classe de angina da CCS, melhoria na qualidade de vida avaliada pela versão abreviada do Seattle Angina Questionnaire (SAQ-7) e redução na terapêutica antianginosa. Vinte e três doentes tinham doença coronária sem alvos de revascularização e três, doença microvascular sem estenoses epicárdicas. O sucesso do procedimento foi alcançado em 23 doentes, com duas complicações relacionadas com dispositivo/procedimento e uma falha na entrega do dispositivo. No total, 24 doentes implantaram o dispositivo e entraram na análise de eficácia. Dezoito doentes (75,0%) sofreram uma redução de pelo menos uma classe CCS, 41,7% sofreram uma redução de pelo menos duas classes e 16,7% tornaram-se assintomáticos, com uma redução média da classe CCS de 1,3±0,2 (p=0,001), seis meses de follow-up. Verificou-se uma melhoria de todos os domínios do SAQ-7, nomeadamente limitação física (p=0,001), frequência de angina (p=0,005) e qualidade de vida (p=0,006). Verificou-se uma redução média de fármacos antianginosos de 3,4±1,1 para 2,9±1,2 (p=0,010). Nesta experiência multicêntrica do mundo real, a implantação do DRSC foi associada à melhoria das queixas anginosas e da qualidade de vida em doentes com angina refratária não passível de revascularização.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".