Abstract
Aim. To determine quantitative criteria for assessing the therapeutic benefits and the most informative time frames after cardiac resynchronization therapy (CRT) to assess its long-term effectiveness (1, 2, 3 years of follow-up) based on retrospective analysis. To assess the CRT effectiveness, parameters of left ventricular (LV) reverse remodeling and signs characterizing the clinical CRT response were considered.Material and methods. This single-center, retrospective, non-randomized study included data from 278 patients with implanted CRT devices. Quantitative criteria for assessing CRT effectiveness were determined using a two-step cluster analysis of patients 1, 2, and 3 years after CRT by LV reverse remodeling parameters.Results. In the dataset with satisfactory division accuracy, after the first year, two clusters were identified, which are conventionally named as “non-responders” and “responders”. Two and three years after therapy, patients were classified into three clusters: “non-responders”, “responders” and “super-responders”. For the obtained clusters, we found cutoff values for LV reverse remodeling parameters, which can be used as criteria for response to therapy.The study identified the most informative time frames for assessing the postoperative CRT effectiveness 1, 2, 3 years after the surgery. At the same time, the clinical response to therapy is manifested earlier in comparison with the reverse LV remodeling.Despite the high divisibility of patients into responders and non-responders, predictive models of CRT effectiveness created using the available data from standard diagnostic protocols for heart failure patients have insufficient accuracy to be used for making decisions on therapy appropriateness. This circumstance indicates the need to receive additional data to improve the forecasting quality.Conclusion. The study revealed a period for assessing the clinical response and changes in LV reverse remodeling after CRT surgery, which is important for the optimal choice of postoperative therapy. It has been shown that in most cases, one year after surgery is sufficient to assess the clinical response, and the process of LV reverse remodeling can last up to two years on average.When assessing the CRT effectiveness by reverse remodeling, along with a change in LV end-systolic volume (ESV), it is necessary to take into account LV end-diastolic volume (EDV) changes. The change in LV ejection fraction showed a significantly lower value among the analyzed parameters in assessing the CRT effectiveness. Based on the cluster classification of patients, a dividing rule was established for responders and non-responders in the first and second years after surgery with an accuracy of 97%: a decrease in LV ESV and EDV by 9% or more compared to preoperative values.
Highlights
We found cutoff values for left ventricular (LV) reverse remodeling parameters, which can be used as criteria for response to therapy
Based on the cluster classification of patients, a dividing rule was established for responders and non-responders in the first and second years after surgery with an accuracy of 97%: a decrease in LV end-systolic volume (ESV) and end-diastolic volume (EDV) by 9% or more compared to preoperative values
Процент снижения конечно-диастолического объема (КДО) левого желудочка (ЛЖ) в первый год после сердечной ресинхронизирующей терапии (СРТ) составлял 17% [-6%; 35%] при значимом отличии процента снижения от нуля (р
Summary
Сокращения: КДО — конечно-диастолический объем, КСО — конечно-систолический объем, ЛЖ — левый желудочек, ФВ — фракция выброса, ФК — функциональный класс, ХСН — хроническая сердечная недостаточность, r — коэффициент корреляции Спирмана, p — значимость отличия r от нуля. Для парных сравнений в первый год после начала СРТ имелась подгруппа из 173 пациентов, из них в 77% случаях ФВ ЛЖ стала больше, в 17% — меньше, в 6% осталась без изменений. Однако дополнительный процент прироста на этапе от 1 до 2 лет достоверно отличался от нуля (р=0,033) и составлял 3% [-10; 24] Для парных сравнений в промежутке от одного до двух лет имелась подгруппа из 119 пациентов, в 54% случаях из них ФВ ЛЖ стала больше, в 43% — меньше, в 3% осталась без изменений. Для парных сравнений в промежутке от 2 до 3 лет после СРТ подгруппа включала 88 пациентов, для 48% случаев ФВ ЛЖ стала больше, для 42% — меньше, для 10% осталась без изменений.
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