Attacher: our devices with the term "attach" are characterized by the controlled attachment of the tissue to an instrument during a particular procedure, e.g. attachment to the pericardium. When tissue attachment is lost for whatever reason, this is recognized and the procedure is stopped until the surgeon regains tissue attachment. Since "attacher" is a common name, sometimes the prefix "Marburg" is used (the devices were developed at the Philipps University of Marburg).
PeriAttacher: a device for puncturing the pericardium, thereby entering the pericardial sac or space.
AttachLifter: a follow-up of the PeriAttacher which fails in the case of thickened (due to fat deposition or fibrosis) pericardium. The device uses a novel procedure for entering the pericardial space.
The setup required is simple and requires a regular suction pump, a control console for monitoring tissue attachment and the PeriAttacher (please note, the device shown is an early prototype not suitable for thickened fatty pericardium).
The principal steps of accessing the pericardial sac involve (in the picture below from left to right): Attachment of the pericardium to the PeriAttacher and puncture of the pericardium with a needle (left), introduction of a guide wire located in the needle used in the puncturing step (middle) and dilation of the opening using dilators with successively increasing diameter (right). When the opening is large enough, other instruments can be introduced into the pericardial space, e.g. an endoscope for taking diagnostic biopsies, and drugs can be instilled.
In view of the many unresolved technical problems, we addressed at first the question whether a minimal invasive access to the pericardium can indeed be achieved. For accessing the pericardial sac with effusion, a system referred to as "PerDUCER" has already been developed by Comedicus Inc. The device involves manual suction with a syringe for attaching the pericardium to the head piece prior to puncture with a needle. Although this procedure has been validated in pigs, it was less successful in patients. In a study performed by Prof. B. Maisch at the Department of Cardiology, Philipps University of Marburg a successful puncture of the pericardium with access to the pericardial sac was achieved in 2 out of 6 patients. This failure rate might not be unexpected taking into account that the attachment to the pericardium was achieved only by manual suction with a syringe and that in parallel to the suction, the needle had to advanced for puncturing the attached pericardium. Any loss of attachment is expected to result in failure of pericardial puncture. Also thickened pericardium would fill out the suction head and the needle would thus not enter the pericardial space.
How to develop devices for a minimal invasive access to the pericardial space?
A prototype of the "Marburg Attacher” for puncturing the pericardial sac (named PeriAttacher for this purpose) is shown below. A fiberscope was attached which could be used for inspecting the tissue before puncturing the pericardium (picture taken during demonstration of the “11284A Vaskular-Fiberskop” of Karl-Storz Endoscopy, Inc., Tuttlingen, Germany). Please note the successful guide wire insertion.
Device for a minimal invasive access to the pericardial space with thickened pericardium
When pronounced pericardial effusion is present, the PeriAttacher could be used for draining the pericardial fluid, taking biopsies and administering drugs. Pericardial effusion can accurately be assessed by cardiac magnetic resonance (CMR) (for avi file with better resolution, see Dr. Peter Alter, Heart Center Marburg) who pioneered in developing CMR-based wall stress calculation, the calculation of "isostress" curves for risk assessment and the assessment of cardiac contractility based on CMR derived presure-volume loops of the heart. A heart with pericardial effusion (right) is compared with dilative cardiomyopathy (center) and a normal heart (left).
It is often assumed that a large pericardial effusion precludes the risk of puncturing the epicardium in the conventional needle approach. The CMR clearly demonstrates that this is not the case, even in a large pericardial effusion, the epicardium touches the pericardium on the front of the chest, i.e. the location where the needle is forwarded. Clearly, it depends on the skills of the cardiologist to avoid puncturing the epicardium and preventing life-threatening cardiac tamponade. In this condition, the use of the PeriAttacher and its follow-up device (not yet disclosed) would represent a safe alternative which excludes any risk of puncturing the epicardium.
© P. Alter
In view of recent progress in diagnostic procedures and treatment options involving the intrapericardial instillation of drugs, the treatment would have already been extended to moderate pericardial effusions if a suitable device had been available. The number of procedures with pericardial access is expected to increase markedly after the PeriAttacher and its follow-up device becomes available.
The access to a normal pericardial sac without effusion would also provide a greatly unexplored approach for drug treatment of diseased hearts using intrapericardial bolus instillation. Interventions could involve instillation of drugs into the pericardial space for the treatment of inflammatory heart disease (myocarditis) in high local dose with little systemic side effects. Of great interest would be also the administration of nitric oxide (NO) donors before or after PCTA.
From S.H. Baek et al.: "Perivascular exposure of coronary arteries to NO via intrapericardial D-BSA administration reduced flow-restricting lesion development after angioplasty in pigs without causing significant systemic effects. The data suggest that intrapericardial delivery of NO donors for which NO release rates and pericardial residence times are matched and optimized might be a beneficial adjunct to coronary angioplasty."
Also anti-arrhythmogenic compounds (e.g. long-chain omega-3 fatty acids) could be administered shortly after myocardial infarction, however, again this requires further research. It can also be envisaged that the procedures for epicardial ablation could be improved by the present devices.
The potential applications of devices using a controlled attachment to tissues or organs with subsequent manipulation procedures are manifold. Since these devices have been developed by cardiologists, the focus is currently on cardiovascular applications, in particular access to the pericardial sac. This does, however, not imply that applications beyond the cardiovascular system could not be of great relevance (therefore also the general name "Marburg Attacher"). Rather, they have just not been explored in detail. For example, it has recently been suggested that the controlled tissue attachment of our devices could be very useful for removing cysts from the uterus or the gastrointestinal tract.
Are there also other routes to the pericardial space?
Our devices have also to be seen in the context of the recent approach by S.R. Mickelsen et al. "Transvenous Access to the Pericardial Space: A Novel Approach to Epicardial Lead Implantation for Cardiac Resynchronization Therapy" involving a transvenous access to the pericardial space which, however, is associated with acute pericardial effusion during the implantation procedure:
"Background: Percutaneous access to the pericardial space (PS) may be useful for a number of therapeutic modalities including implantation of epicardial pacing leads. We have developed a catheter-based transvenous method to access the PS for implanting chronic medical devices.Methods: In eight pigs, a transseptal Mullins sheath and Brockenbrough needle were introduced into the right atrium (RA) from the jugular vein under fluoroscopic guidance. The PS was entered through a controlled puncture of the terminal anterior superior vena cava (SVC) (n = 7) or right atrial appendage (n = 1). A guidewire was advanced through the transseptal sheath, which was then removed leaving the wire in PS. The guidewire was used to direct both passive and active fixation pacing leads into the PS. Pacing was attempted and lead position was confirmed by cine fluoroscopy. Animals were sacrificed acutely and at 2 and 6 weeks. Results: All animals survived the procedure. Pericardial effusion (PE) during the procedure was hemodynamically significant in four of the eight animals. At necropsy, lead exit sites appeared to heal without complication at 2 and 6 weeks. Volume of pericardial fluid was 10.8 ± 6.2 mL and appeared normal in four of the six chronic animals. Moderate fibrinous deposition was observed in two animals, which had exhibited significant over-procedural PE. Conclusions: Access to the PS via a transvenous approach is feasible. Pacing leads can be negotiated into this region. The puncture site heals with the lead in place. Further development should focus on eliminating PE and performing this technique in appropriate heart failure models.
Our devices for epicardial lead implantation and ablation:
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© H. Rupp
Dr. H. Rupp
Professor of Physiology
Experimental Cardiology Laboratory
Department of Internal Medicine and Cardiology
Heart Center, Philipps University of Marburg
Baldingerstrasse 1, 35043 Marburg, Germany
Tel. +49 6421 586 2775
August 23, 2013
The AttachLifter and related tools have been developed at the Department of Internal Medicine and Cardiology of the Heart Center and the Technical Development Plant of the Medical Center and Medical Faculty of the Philipps University of Marburg, Office for Research and Technology Transfer
The team involved in the production of the Marburg Attacher and follow-up devices:
Prof. Dr. Heinz Rupp
Prof. Dr. Bernhard Maisch
Dr. Thomas P. Rupp, M.D.
Patent application and marketing is in cooperation with TransMIT (for the Transfer Center of the Philipps University)
For technical information on the AttachLifter, please contact
Prof. Dr. Heinz Rupp
For information on the pending patents of the AttachLifter and follow-up devices, please contact Dr. Peter Stumpf, Managing Director, TransMit or Heinz Rupp.
For information on live demonstration of the AttachLifter and follow-up device in the pig, please contact Dr. Thomas P. Rupp, M.D.
Prof. Maisch is the chairperson of "The Task Force on the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology": Guidelines on the Diagnosis and Management of Pericardial Diseases Executive Summary.
Advantages over currently available products.
1. truely minimal invasive access to the pericardial space.
2. No competing device available that works for thickened pericardium.
5. Pioneering technology with prospects of future intrapericardial therapy interventions.
Clinical advantages. The procedures minimize the risk of life-threatening cardiac tamponade and permit also access to the normal pericardial space.
The Attacher/AttachLifter represent an entirely new procedure with no current competition.
Extensive experience has been accumulated with respect to the conventional access to the pericardial sac using a needle. This requires, however, pericardial effusion which clearly separates the epicardium from the pericardium and thus prevents puncture of the myocardium leading to life threatening cardiac tamponade. The needle technique is obviously not applicable to patients with normal pericardium but impaired heart function. This has been stated by Prof. B. Maisch: "Whilst advocating the advantages of pericardiocentesis in appropriate cases of pericarditis, Dr Maisch points out that many cardiologists are fearful of using the technique unless severe cardiac tamponade is present, a situation in which, he estimates, the volume of the effusion is at least 500 ml. He said, “At Marburg we perform pericardiocentesis in the presence of as little as 100 ml of fluid, or sometimes even 50 ml. But I would not recommend this to the ‘normal’ cardiologist, as there is a high risk of damage to the heart. But I think the subxiphoidal approach should be used more widely, because it’s safer and makes it easier to perform a full aetiological diagnosis as well as to take off fluid.”
Experience has been gathered during testing of the "PerDucer" device of Comedicus Inc. which unfortunately can fail since it does e.g. not monitor the actual attachment of the pericardium before the puncturing step.
The key technology is now available for accessing the pericardial space in a truely minimal invasive approach. The AttachLifter provides a solution to the critical step of tissue puncturing by monitoring tissue attachment before the puncturing step. The AttachLifter permits puncturing of thickened pericardium.
Research described here is based on limited funding by the Marburg Cardiac Society and is not sponsored by medical device companies. Please support the projects by a donation through the Marburg Cardiac Society which is a non-profit organization. For details, please contact
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