ALWAYS CLOSE TO YOUR HEART
Patients diagnosed with coronary artery disease (CAD) suffer from chest pain (angina) and a lack of blood flow to the heart muscle (myocardial ischemia). The decrease in blood flow reduces the heart’s oxygen supply and can damage the heart muscle, ultimately leading to a heart attack. Extracorporeal Shockwave Myocardial Revascularization (ESMR™) is a non-invasive, alternative treatment for chest pain caused by myocardial ischemia. ESMR stimulates growth of new coronary blood vessels (angiogenesis) using low-energy focused shock waves. ESMR is a proven and safe therapy that is used in more than 60 medical centers worldwide. Patients benefit from a reduction in chest pain and an opportunity to resume normal activity.
Frequently Asked Questions
Who can use the Cardiospec?
What are the inclusion criteria for treatment?
What are the exclusion criteria for treatment?
Patients with the following conditions (selected list):
- Patients with intracardiac Thrombus
- Patients with malignancy at the area of treatment
- Pulmonary disease (emphysema) that blocks the acoustic window
Warning and precautions...
- The candidates of this treatment are usually taking anti-aggregates on a regular basis. There is no treatment limitation in patients treated with Aspirin or Clopidgrel. The treating physician should take into consideration the bleeding tendency resulting from their intake and might consider changing anticoagulant regimen prior to shock wave treatment to prevent local hematoma
- In order to be able to treat patients treated with Warfarin: INR levels should be close to 2 to 3.
- In patients treated with Heparin – PTT levels should be below 60
- Although there is no limitation in the treatment of patients with cardiac pacemakers or artificial cardiac valves, caution should be taken in treating these patients.
Although there is no limitation in the treatment of patients with Automatic Implantable Cardioverter Defibrillator (AICD), or Cardiac Resynchronization Therapy (CRT), caution should be practiced in these patients
Is it necessary to hospitalize the patient?
No. Although no side effects were reported so far, patients at high risk (poor hemodynamic conditions) are recommended to stay in the hospital for monitoring following the treatment.
I have heard that the shock wave applicator (lithotripter) in the Urology department is noisy and there is a need to wear ear protection. Is it required during cardiac applications?
No. Unlike Urologic applications, Cardiac shock wave therapy requires less powerful shock waves (1/10th of Lithotripsy). For that reason the CardiospecTM is fitted with a smaller generator, producing less intense electrical sparks thus generating significantly less noise. There is no need to wear ear protection during treatment.
Is it possible to use shock wave therapy after PCI/CABG?
Yes. It is possible if the patient has a proven ischemic zone.
Is it possible to use shock wave therapy with SVT's (i.e. AFIB)?
Yes. It is possible, as shock waves are delivered during the R-wave.
Is it possible to use shock wave therapy on patients with pace-makers?
Yes. It is possible, as shock waves are delivered during the R-wave. Also, safety tests have demonstrated no effect of shock-waves on the function of the pace-makers.
How soon after PCI/CABG can the patient undergo a shock wave therapy?
As soon as the patient is stabilized (including hemodynamic stability), it is possible to start shockwave therapy.
Is there a need for special pre treatment procedure?
Patients should be at the maximum tolerable dose of two or more antianginal drugs for at least 6 weeks prior to treatment. Also, anti-coagulation medication should be monitored.
Why was this protocol chosen?
Do shock waves cause arrhythmias?
No. The delivery of shock waves is synchronized with the patient’s R-wave.
During this period, the heart is in its refractory phase, thus, another action potential cannot be produced eliminating the risk for arrhythmia. The synchronization serves another purpose as well, as a means for precision in delivery of treatment as the heart will be at the exact state (End-Diastole) for every shockwave pulse.
What should I do if the patient has extrasystole?
The Cardiospec is equipped with two modes for delivering shock waves. Automatic mode and Manual mode. When the patient has a history of ventricle extrasystole, the Cardiospec should be in Manual mode, thus, delivery of shockwaves using the Remote control by the user. When the E.C.G. monitor shows an extrasystole then the user should delay the delivery of shockwaves at least for 3 seconds.
In addition, the Cardiospec is equipped with a safety mode, that does not allow the delivery of shockwaves in an interval that is less then 500 ms. Thus, if another R waves is generated in less than 500 ms than the previous one, shockwaves will not be delivered (even if in Automatic mode).
Can I see the treatment site during delivery of shock waves?
Yes. There is no need to move the ultra-sound probe during treatment. Shock waves can be delivered safely with real-time view of the treatment site.
What does the patient feel during treatment?
The patient sometimes feels a tickling sensation in the chest during treatment. Some patients feel dizziness. All these effects pass immediate or shortly after the treatment is stopped.
Are there any side effects?
No. There were no reports of side effects during, immediately after or post treatment.
There was no pain associated and no signs of local hemorrhage. Vital parameters, cardiac enzymes and ECG were unchanged. In addition, there was no indication of arrhythmias and new wall motion abnormalities.
Is it possible to undertake repeated sessions?
Yes. Shock waves could be delivered as long as there is a clinical need for collaterals development.
Is there a need for special post treatment procedures?
No, but if needed, it is recommended to monitor cardiac enzymes and controlled ECG. All showed negative in the studies performed.
Is there a change in the medication after treatment?
Yes. There is a reduction of at least 85% in the weekly intake of Nitrates after treatment.
How can I know, if the improvement in perfusion is the result of the therapeutic stimulated angiogenesis or due to the natural angiogenesis process in ischemic tissues?
Several results could confirm that the effect is true therapy and not “placebo” effect.
- ESMR improved myocardial perfusion only in the region where SW’s were applied. Ischemic areas not treated stayed ischemic
- Patients treated have chronic stable angina class III or IV without change prior to treatment
- In vivo controlled studies confirm the significant increase in the number of collaterals at the treated zones compared to the non-treated ones
In cases with no significant change in patient angina, how can I make sure therapy was provided as it does not have an immediate effect?
One should distinguish between technical and operational malfunction and unfavorable patient characteristics when analyzing the results. In order to reduce the chance for a malfunction, the user has to make sure the following:
- The shockwaves are generating sound when triggered
- No presence of air bubble inside the SWA
- The SWA was used within its guaranteed lifespan
- The membrane is with full contact with patient skin with no wrinkles
- Ultra-sound gel (without air bubbles) is used and is covering completely the SWA membrane part that is in contact with patient skin
- Applying shockwaves at the same area during the same week, and changing it during the next week of treatments
- Allowing 3 weeks between weeks of treatments, in order not to destroy the delicate vasculature that is created, when applying new shockwaves as the same region
Some patient characteristics may also alter the effect, such as previous or on-going smoking or diabetes. With diabetic patients, there might be a need for repeated sessions to achieve therapeutic effect. So far, a success rate of 70% was reported.
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