Method for optimising atrioventricular delay in patients with cardiac resynchronising therapy

FIELD: medicine.

SUBSTANCE: continuous monitoring and ECG recording are performed. The ECG findings are used to specify a delay in shape of R wave and a length of an antrioventricular interval. The final result of atrioventricular delay is a symmetrical crowned P wave.

EFFECT: method provides increasing the effectiveness of cardiac resynchronising therapy by reducing complications and improving the patient's quality of life.

1 tbl, 1 ex, 1 dwg

 

The invention relates to medicine, namely to cardiology, and can be used for the treatment of chronic heart failure in patients with implanted cardiac systems.

The use of cardiac resynchronization therapy (CRT) in patients with chronic heart failure functional class showed significant decrease of the disease symptoms, improving the quality of life, fewer hospitalizations and mortality [Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM: Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004; 350: 2140-2150; Bradley DJ, Baughman KL, Berger RD, Calkins H, Goodman SN, Kass DA. Powe NR. Cardiac resynchronization and death from progressive heart failure: a meta-analysis of randomized controlled trials. JAMA. 2003 Nov 12; 289(6): 730-40]. However, one third of patients with implanted CRT devices do not respond to this type of treatment that requires the identification and correction of contributing factors. One of the most frequent causes of insufficient response to CRT is suboptimal atrioventricular delay (FD occupations) [Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J: Cardiac resynchronization in chronic heart failure. N Engl J Med 2002; 346: 1845-1853; Cleland JG, Freemantle N, Erdmann E, Gras D, Kappenberger L, Tavazzi L, Daubert JC. Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial. EurJ Heart Fail. 2012 Jun; 14(6): 628-34]. To date, there is no universal optimization method FD occupations [Patrick Houthuizen. Frank A L E Bracke. Berry M van Gelder: Atrioventricular and interventricular delay optimization in cardiac resynchronization therapy: physiological principles and overview of available methods. Heart Failure Reviews 2011; 12; 16(3): 263-276; Vardas PE, Auricchio A, Blanc JJ et al.: Guidelines for cardiac pacing and cardiac resynchronization therapy: the task force for cardiac pacing and cardiac resynchronization therapy of the European society of cardiology. Developed in collaboration with the European Heart Rhythm Association. Eur Heart J 2007; 28(18): 2256-2295].

The most known and used and echocardiographic automated algorithms for analysis FD occupations. However, the subjectivity of the method of echocardiography (ECHOCG), high measurement accuracy, and the inability to change the algorithms for automated selection FD occupations in some cases can cause a decrease the effectiveness of resynchronization therapy and worsening of CHF clinic [Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J, Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20; 117(20): 2608-16, Thomas DE, Yousef ZR, Fraser AG. A critical comparison of echocardiographic measurements used for optimizing cardiac resynchronization therapy: stroke distance is best. Eur J Heart Fail. 2009 Aug; 11(8): 779-88].

Optimal atrioventricular delay for CRT devices represents a time interval during which fills with blood to the ventricles through the atrio-ventricular pressure gradient during diastole (�assigny period) and by reducing - systole of the Atria (the active period). After the optimal interval FD occupations comes the contraction of the ventricles - biventricular stimulation with a maximum preloading. The expected effect of such a temporal correlation - increasing pressure gradient of blood in the ventricular myocardium and therefore the increase in the stroke volume and cardiac output. When extending the interval FD occupations occur conditions to late diastolic regurgitation of blood through the atrioventricular valves by the pressure gradient back into the Atria, which leads to the syndrome of small emissions, increased pressure in the pulmonary circulation and worsen CHF. Excessively short FD occupations leads to insufficient filling of blood in the ventricles of the heart is interrupted due to the systole of the Atria, which also reduces stroke volume and cardiac output [Yaariv Khaykin, Derek Exner. David Birnie et al. Adjusting the timing of left-ventricular pacing using electrocardiogram and device electrograms. Europace. 2011, 13: 1464-1470].

Impact of drug therapy on the conductivity of the myocardium, different PR intervals surface ECG when the conduction in the myocardium (normal or prolonged PR interval), interatrial delay - blockade intraatrial and the change of parameters in time - exercise, rest, reverse remodeling myocar�and - all these factors contribute to the feasibility of dynamic optimization in FD occupations CRT devices [Steven R. Bailey, Andrew E Epstein, Paul A Heidenreich et al. ACCF/HRS/AHA/ASE/HFSA/SCAI/Marsaxlokk as its next/SCMR 2013 Appropriate Use Criteria for Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy. Heart Rhythm. April 2013; 10(4): 2-48].

One non-invasive way to optimize FD occupations can be considered electrocardiographic method. Pathophysiological rationale of this approach is that the P wave on surface ECG reflects the electrical systole is the depolarization of the right and left Atria. FD occupations selected on the basis of morphology and duration of your own teeth and stimulated R, where the end result interval FD occupations is taken symmetrical finished the P wave in lead with the best visualization - often in the II standard lead ECG [Cristian Statescu, Radu A. Sascay, Vasile Maciuc et al. Programming an Optimal Atrioventricular Interval in a Dual Chamber Pacemaker Regional Population. Maedica a Journal of Clinical Medicine 2011, 6 (4): 272-276].

From the known analogues and prototype to the claimed method is selected method of dynamic optimization FD occupations on the basis of atrial electrogram Quik-Opt [Ravindu Kamdar, Evelyn Frain, Fiona Warburton et al. A prospective comparison of echocardiography and device algorithms for atrioventricular and interventricular interval optimization in cardiac resynchronization therapy. Europace 2010, 12: 84-91]. This type of selection FD occupations relates to automated algorithms of the manufacturer of the pacemaker St. Jue Medical (USA). For optimal detektirovanie FD occupations taken time calculated from the beginning of atrial electrogram up to its end - atrial time of the pulse (electrical activation of the right and left Atria) with the addition of index +30 MS, if the timing of ≥100 MS, or +60 MS when the time of the <100 MS. Stimulated FD occupations is defined as the sum of the interval detektirovanie FD occupations +50 MS. The value of the index increases are empirically selected and reflects the average time interval for the completion of the mechanical systole of the Atria. Selection FD occupations using the algorithm Quik-Opt can be carried out during the programming CRT devices; automatic selection FD occupations without a doctor impossible [Ravindu Kamdar, Evelyn Frain, Fiona Warburton et al. A prospective comparison of echocardiography and device algorithms for atrioventricular and interventricular interval optimization in cardiac resynchronization therapy. Europace 2010, 12: 84-91]. In a randomized controlled study of FREEDOM (A Frequent Optimization Study using the Quick Opt Method comprising 1647 patients, we demonstrated the effectiveness of dynamic optimization FD occupations in this way, comparable with echocardiographic methods [Abraham WT, Gras D, Yu CM et al. Results from the FREEDOM trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy. Abstract SP08. Late-Breaking Clinical Trials, HRS 2010. Denver, Colorado].

The main disadvantages of the above-described method of optimizing FD occupations are: the need required�of the device only with this manufacturer, the inability to adjust settings of the automated algorithm, empirical indices to calculate the total FD occupations, dependent on the settings of the CPT system (the level of sensitivity on the atrial channel, the recording quality of electrogram).

The technical result achieved by the invention is to improve the hemodynamic response of the myocardium of the left ventricle, with the consequent increase of its systolic function due to selection of the atrio-ventricular delay based on the morphology of the P wave with the trend towards a narrowing of the stimulated QRS complex on surface ECG.

The claimed technical result is achieved in a method for optimizing atrioventricular delay in patients with cardiac resynchronization therapy based on surface ECG registration. According to the invention is the selection of the atrio-ventricular delay when the continuous recording of ECG, wherein the delay is selected according to the shape of the P wave, the duration of atrioventricular interval; for the final result of the atrio-ventricular delay is taken symmetrical finished prong R.

The difference between the proposed method from the prototype is the principle of optimization of FD occupations with only electrocardiographic data.

The claimed invention is new, as identical sookun�STI signs in the reviewed literature is not detected. Distinctive features showed in the inventive combination of new properties that are not explicitly derived from the prior art in this field and not obvious to the expert.

The proposed technical solution can be applied in medicine, particularly in cardiology.

Based on the above, you should consider this solution with the relevant conditions of patentability: novelty", "inventive step", "industrial applicability".

The method is as follows.

For the selection of FD occupations employ a system for monitoring and recording ECG with standard and reinforced leads. During programming FD occupations selected on the basis of the ECG in the form of your own teeth and stimulated R, the duration of a native atrioventricular interval, the width of the excited ORS complex in lead with the best visualization. For a end result accepted FD occupations symmetrical finished the P wave as their own, and stimulated.

The method is illustrated by the following clinical example and the circuit of Fig.1, which illustrates the procedure of the selection of FD occupations (patient K., selection PG - detection):

A - measurement of P-wave - 134 MS,

B - excessively short FD occupations - 85 MS: PR interval is 120 MS, QRS complex - 209 MS,

In long FD occupations - 130 MS: PR interval 167 MS, visible from�line between the P wave and QRS; the QRS complex is 199 MS,

G - optimal FD occupations - 100 MS: PR interval of 136 MS, the QRS complex is 192 MS.

Example. Patient S. 62 years with coronary heart disease, postinfarction cardiosclerosis (transmural myocardial infarction from 2008) with the outcome in dilated cardiomyopathy, functional class III heart failure (NYHA). Condition after angioplasty with stenting of the circumflex artery from 2009, According to the ECHO - reduced LVEF (25%), ECG - sinus rhythm, complete blockade of the left bundle branch (PAMNG), prong R - 134 MS, interval PQ 204 MS, QRS - 191 MS. 21.08.2011 implanted system resynchronization therapy with function defibrillation, CRT-D with positioning propresenter electrode in the left atrial appendage, right ventricular electrode in the apex of the right ventricle, the left ventricular electrode in a lateral coronary sinus vein (basal section). After implantation of the device is made of standard programming Protocol with the selection of FD occupations on the shape of the P wave in private and stimulated atrial events selected FD occupations detection/stimulation 90/125 MS; the original value FD occupations default was 100/130 MS; sensitivity to R - 0.3 mV. Left synchronous biventricular stimulation. During the control visit after 3 months, marked by moderate positive dynamics of size and LV volumes, ejection fraction. Then at each ambulato�nom programming CPT apparatus according to the scheme 0-3-6-12 months selection was carried out FD occupations, control ECHOCARDIOGRAPHY.

Dynamics of ECG, FD occupations, echocardiographic parameters at 12 months of follow-up this patient presented in the table.

After 12 months from the date of implantation of the device revealed a significant increase in LVEF, decrease the size and LV volumes, the clinical effect in the form of increased tolerance to physical activity, reduction of FC (NYHA) according to the test with a six-minute walk.

This example demonstrates the versatility of measurements, reproducibility, and safety of the proposed method FD occupations optimization in CRT devices. Ease of practical application without the use of additional time and financial resources, the possibility of correction of septal myocardial dyssynchrony on the basis of ECG data indicate the advantages of the proposed method of selection FD occupations before known algorithm Quik-Opt. The inventive method allows to increase the effectiveness of cardiac resynchronization therapy to reduce FC CHF, improve the quality of life of patients. Thus, the proposed method of optimization of atrioventricular delay in patients with cardiac resynchronization therapy based on surface ECG is an important part of active surveillance and treatment of patients with high FC and it has been successfully implemented in practice.

A method for optimizing atrioventricular delay in patients with cardiac resynchronization therapy based on surface ECG registration, characterized in that carry out the selection of the atrio-ventricular delay with continuous monitoring and recording of ECG, wherein the delay is selected based on the ECG by the shape of the P wave, the duration of atrioventricular interval and for the final result of the atrio-ventricular delay take symmetrical finished barb R.



 

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1 ex

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