Dynamic cardiomyoplasty (DCMP) aims at improving cardiac function in cases of severe heart failure by wrapping the latissimus dorsi (LD) muscle, (usually left LD) around the ventricles and stimulating it electrically, synchronously to the ventricular function (Figure 1, Figure 2).
It is a surgical treatment option mostly for pharmacologically untreatable heart failure. The first successful clinical application was performed in 1985 (Broussais Hospital, Paris, [1]). Since then, more than 1.000 surgeries have been performed worldwide [2]. The clinical results of the DCMP however did not live up to the expectations due to the loss of muscle strength [3][4] and muscle damage [5][6].

In DCMP, a special kind of tissue engineering is applied using an electric stimulation on autologous skeletal muscles (electrical muscular tissue engineering). The fiber type changes from the fatiguing type IIa to the fatigue resistant type I [7], [8]. Type IIx fibers disappear. The gene expression for myosin heavy chains IIa (MHCII) is changed into heavy chains I (MHCI) [3]. Intramuscular collaterals are opened [9], [10] and enhanced and capillary density is
increased [11].

A critical analysis of more than 20 years and more than 1.000 clinical cases should demonstrate it’s clinical impact [1], [2], [4–6], [12–145]. Clinical efficacy concerning survival, clinical outcome indicated by NYHA- class, ejection fraction of the left heart ventricle (EF) was evaluated by the use of more than 100 relevant reports.

Indications and Contraindications for the Dynamic Cardiomyoplasty

In non-drug responding end-stage heart failure patients in NYHA III mainly the following pathologies are found: cardiomyopathies of inborn or infectious myocardial diseases, ischemic cardiomyopathies and an isolated right heart failure likewise in a chronic pulmonary hypertension. These patients mostly being older than 60 years have limited chances to receive heart transplantation. In cardiomyoplasty impressive therapeutic responders are heart failure patients with an isolated insufficiency of the right heart ventricle. Most candidates for a DCMP however suffer from an idiopathic cardiomyopathy or from an ischemic heart failure. Infectious myocardial disease like the Chagas disease, were treated as well by a cardiomyoplasty are primary limited to South America.

Indication

• Adults with idiopathic or ischemic, dilative cardiomyopathy or isolated right heart failure
• Non drug respondent myocardial failure NYHA III and
• A left ventricular ejection fraction > 15% und < 40%
• Non responder for resynchronization therapy and a contraindication for a heart transplantation or shortage in donor organs

Contraindications

• NYHA classification IV
• Intravenously applied inotropic drugs
• Intra-aortic balloon pump dependency
• Injured latissimus dorsi muscle
• Mitral or tricuspid heart valve insufficiency > Grade II
• Pulmonal resistance > 275 dyn/s/cm
• Pulmonary hypertension with a PCWP > 27mmHg
• Left ventricular end-diastolic volume > 110 ml/m²
• Left ventricular diameter > 75 mm or heart-/ thoracic ratio > 0.6
• Left ventricular end-diastolic pressure > 35 mmHg
• Maximal cardiac VO2-reserve under working conditions: VO2max < 10ml/kg/min
• Atrial fibrillation > 100bpm, under drug therapy
• Lung capacity < 60%
• Creatinine of the serum > 2,8 mg/dl
• Pronounced liver failure
• Coagulation disorders
• Pronounced ventricular extra-systoly
• Cardial cachexia

Intended Use and Operation of the MyoSen Myo-Stimulator

Intended Use

The MyoSen muscle stimulator system is built to support cardiomyoplasty, a surgical treatment option for end-stage heart failure. 

It stimulates a skeletal muscle, which has been wrapped around the heart. This autologous muscle is stimulated synchronously to the heart action.

Application of the Implant

The single use muscle stimulator is implanted under sterile conditions into the abdominal wall or in special cases into the chest wall. Its topography may be subcutaneous, in adipose tissue, subfascial or  submuscular with contact to fatty, connective or muscular tissue. The implantation depth should not exceed 50 mm providing a failure-free telemetric communication between programmer and implanted device.

As sensing electrodes for the ventricular electrocardiogram (EGM) serve sterile, unipolar or bipolar electrodes for permanent use. The electrodes have to be sufficient long and have to be equipped with an IS-1 profile connector. 

The sensing electrodes should provide a QRS-signal with a amplitude of >= 5mV and a slope >= 0.5 V/s. 

The stimulation pulses for the muscle are delivered by single-use, bipolar Myo-Sen Muscle Stimulation Electrodes¹ implanted under sterile conditions. 

The single-use, sterile torque wrench equipped with a hexagon socket, M2 is used to fasten the electrodes in the header of the muscle stimulator.

Nominal battery life is six years with a common pulse pattern².

 At end of battery lifetime , the muscle stimulator can be replaced by a separate surgical procedure.

A MyoSen Programmer is required for the telemetric programming of the implant.

______________________

¹ The MyoSen Muscle Stimulation Electrodes have an impedance of 150 to 180 Ω and more than 10 mm² anode or cathode surface

² Using muscle electrodes with a combined (electrodes/tissue) impedance of 300 Ω: amplitude 5V,  pulse width 240µs, pulse interval 30 ms, 6 pulses per burst, 10000 bursts per day

The Microstim MyoSen Muscle Stimulator System (under development)

A detailed description of the Microstim MyoSen Muscle Stimulator System can be found in the technical documentation.

The Muscle Stimulator System comprises:
Implantable components:

• Muscle stimulator (sterile)
• Myocardial sensing electrode (sterile)
• Muscle stimulating electrode (sterile)

and non-implantable components:

• Torque wrench, hex-key, M2 (sterile)
• Programmer (tablet-based, with integrated programming head)

The muscle stimulator consists of an electronic module, a battery, a titanium housing and an epoxy resin header containing the connectors.
Its muscular stimulation output channel is synchronized to its cardiac sensing channel by a microcontroller running a controlling software.

The cardiac sensing channel is capable to record a ventricular electrocardiogram (ECG). The muscular stimulation channel provides a programmable muscular stimulation pattern.
The controlling software synchronizes the muscular stimulation output to the cardiac signal.
Both, the sensing and the stimulation channel can be operated ins a monopolar or bipolar configuration. In a monopolar configuration, the titanium housing serves a anode and the unipolar electrode as cathode.
As cardiac sensing electrode, a custom implantable electrode for epicardial ventricular placement and permanent use, equipped with an IS-1 plug may be used. It should deliver a myocardial ECG amplitude >= 5 mv.
The bipolar MyoSen Muscle stimulation electrode consists of conductive coil structures with platinum-iridium contact surfaces, coiled conductors, silicone coating and a IS-1 compatible plug, whih is protected against polarity reversal.
The materials in contact with tissue comprise titanium, epoxy-resin, silicon and platinum-iridium.

The Microstim MyoSen muscle stimulator system is still under development. 
First clinical applications are due late 2015.

For experimental studies concerning the influence of electrostimulation to the power development of skeletal muscle, a large animal study using an intra-thoracic elastic training device has been performed.   

	Figure A: Evaluation of the muscle induced pressure, stroke volume and delivered daily energy using an elastic training device. In Figure A, top left, the elastic training device is demonstrated which is made from silicone rubber including a non- distensible central chamber and two elastic side-bladders (Frogger). The device is filled with saline solution. Latissimus dorsi muscle is placed intra-thoracic and wrapped around the central chamber of the training device. After electrical stimulation of the latissimus dorsi muscle, the central chamber of the device is compressed and a stroke volume is shifted into the elastic side bladders. Puncturing a subcutaneously placed measuring chamber, which is connected with the cavum of the central chamber, the pressure within the cavum is measurable. Correlating the pressure P developed by a muscle contraction with the pressure-volume curve of the elastic side bladders (bottom left), the stroke-volume V can be calculated. Multiplying the stroke volume V with the pressure P and the number of muscular contraction per day, the daily energy delivered by the muscle can be calculated (Guldner NW, Eichstaedt HC, Klapproth P, et al. Dynamic training of skeletal muscle ventricles: a method to increase muscular power for cardiac assistance. Circulation. 1994;89:1032–1040.).
	Figure B: Visualization of the course of the daily energy delivered from the skeletal muscle ventricle during a muscle fiber transformation over several months from Type II to Type I fibers. After transformation into 100% Type-I fibers, the amount  of the energy delivery is reduced to clinically non relevant values
	Figure C: Diagram about the influence of an increasing mean stimulation frequency on the composition of muscle fibers in the rabbit. Shown is a frequency dependent transformation of strong Type-IIA fibers to 100% weak Type-I fibers (Lopez-Guajardo A, Sutherland H, Jarvis JC, Salmons S. Induction of a fatigue-resistant phenotype in rabbit fast muscle by small daily amounts of stimulation. J Appl Physiol 90: 1909–1918, 2001).     This basic research by the group of Stanley Salmons showed the correlation between the mean electrical stimulation frequency and the fiber transformation. The mean electrical stimulation frequency is calculated by relating the number of pulses delivered to the muscle to the elapsed time in seconds. Figure C demonstrates that an increasing mean stimulation frequency changes all Type-IIA – muscle fibers into 100% Type-I fibers. These findings confirms our results shown in figure B.
	Figure D shows the influence of a mean stimulation frequency of 5 Hz (left vertical diagrams) and 1 Hz (right vertical diagrams) on pressure, stroke volume and daily energy of skeletal muscle ventricles using the elastic training model in the experimental setting of figure A using 2 groups of six Bore Goats each.     The limitation of the mean stimulation frequency to 1Hz shows in figure D impressive higher pressures, stroke volumes and daily energies. These results were path breaking for the development of the muscle preserving MyoSen- myostimulator.
	Figure E: Histologic findings after 5 months of electrical stimulation with 5Hz with an extensive muscle damage and a replacement of muscle fibers by fatty cells (left). Applying a mean stimulation frequency of 1 Hz the muscle fibers are preserved (right).
	Figure F: Gel electrophoresis of myosin heavy chains (MHC) of group A with a mean stimulation frequency of 5 Hz and group B with a mean stimulation frequency of 1Hz.     Control C shows the MHC II and MHC-I fraction of the non- electrically stimulated latissimus dorsi muscle of the contra-lateral muscle of goats from group A or B. In group A, stimulated by 5 Hz, 100% of MHC-I has been expressed. In group B, stimulated by 1Hz, the MHC-II / MHC-I composition approximates a 50% to 50% distribution.

Summary

Studies with large animals (goats) showed, that a mean stimulation frequency of 5Hz, similar to that used in former years clinically in cardiomyoplasties, results in severe muscle damage. Using a mean 1 Hz stimulation however, the muscle tissue has been preserved. A mean 1 Hz stimulation equates a delivery of 86.000 pulses per day. The MyoSen- muscle stimulator enables such a reduced and controlled pulse delivery preserving the muscle tissue.

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