Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans

Study Overview
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Brief Summary
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Particularly in CRT (Cardiac Resynchronisation Therapy), limited accessibility of the coronary sinus along with its branches and the mismatch between the region of latest left ventricular (LV) contraction and an adequate epimyocardial vein frequently lead to therapy failure and might even be responsible for the 30 % non-responders, although this aspect has not been thoroughly investigated yet. Further complications such as postoperative micro- (i.e. increased thresholds) or macro-dislodgement (i.e. loss of stimulation success) of the LV electrodes are frequent complications leading to reoperation or a change of strategy. The current transthoracic epimyocardial approach via mini-thoracotomy circumvents the aforesaid obstacles and is regarded as the first-choice alternative approach. Participation in the trial would prevent patients from this invasive, transthoracic approach and at the same time allow the same degree of freedom in lead placement. Risks and complications are in this case comparable to the open surgical approach but with a lower risk of intraoperative rib fracture, postoperative pain with consecutive pulmonary hypo-ventilation and pneumonia. Apart from the benefit of the single individual, societies benefit will include a much higher responder rate in CRT patients and less lead-associated infections. Thoracotomy with breach of the pleural cavity and single lung ventilation - a procedure that itself bears a high risk for postoperative atelectasis, pleural effusion and infection will be avoided. In patients on hemo-dialysis and patients who suffer from an infected pacemaker-system, extravascular lead placement should be preferred. Again, the current open, transthoracic epimyocardial approach via mini-thoracotomy is regarded as the first-choice alternative approach. Aim of this study is the validation of the feasibility of an alternative, minimal-invasive therapy method for implanting a cardiac pacemaker.

Detailed Description
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Treatment: Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker leads Abridged Operation Protocol: 10 mm skin incision below the xiphoid process, blunt preparation towards the pericardial sac, insertion of the endoscope-carrying trocar, opening of the pericardium with endoscopic forceps, standardised inspection of the pericardial cavity, insertion of the bipolar Stingray® electrode via the endoscope working channel into pericardial space, implantation of the electrode into designated epimyocardial site under endoscopic vision, pacing measurements sensing, impedance, pacing threshold, interventricular delay (in CRT), panoramic fluoroscopy for future controls, retraction of the endoscope/trocar, subcutaneous tunnelling and connection of the respective electrode to: existing, infraclavicular CRT device, suture in layers, wound dressing a single- or dual-chamber pacemaker device implanted epigastrically, suture in layers, wound dressing

Official Title
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Video Assisted Pericardioscopic Surgery: Minimal-invasive Implantation of Epimyocardial Pacemaker Leads in Humans (VAPS - A Pilot Study)

Conditions
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Dysrhythmia, Cardiac, Heart Failure, Pacemaker Electrode Infection, Hemodialysis-Induced Symptom, Bradycardia

Intervention / Treatment
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* Device: StingrayTM, Medtronic®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will include patients who are planned to undergo a pacemaker therapy within their regular medical care and who are eligible for an alternative approach for lead placement (minimal-invasive pericardioscopic surgery): I. Patients fulfilling current, sophisticated criteria for cardiac resynchronisation therapy (CRT) (e.g. patients with symptomatic heart failure independent of functional class, prolonged QRS-duration (especially left bundle branch block), severely depressed systolic left ventricular function), but have a history of failed CRT lead implantation or showed insufficient resynchronization after conventional CRT treatment, OR II. Haemodialysis patients fulfilling the criteria for an implantation of a cardiac pacemakers due to bradycardiac dysrhythmia, OR III. Patients suffering from acute pacemaker-lead-infection, who require system-explantation and concomitant implantation of a new system Further inclusion criteria: Patients aged 18 years or above Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel. Signed informed consent prior to study participation. Exclusion Criteria: Euro Score II (http://www.euroscore.org/calc.html) > 20 % Patients in NYHA functional class IV Previous cardiac surgery / sternotomy Previous pericarditis Gender-independent myocardial wall thickness less than 5 mm Coexisting cardiac/vessel aneurysmata Patients with myocardial infarction within the last 4 weeks Pregnancy and breast-feeding Patients who are accommodated at judicial or official requests Patients with known anomalies of the cardiac anatomy Patients for whom beclometasone dipropionate is contraindicated Patients with bleeding disorders and coagulopathy Patients with a life expectancy below 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>StingrayTM, Medtronic® | Device: StingrayTM, Medtronic®<br>* Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead model 09090, Medtronic®<br>* Other names: Clinical Investigational Lead Model 09090;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative mortality | The mortality will be documented as in the usual clinical routine. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate or severe operative complications | Operative complications (e.g. cardiac tamponade, severe bleeding, infection, lead dislodgement, pacing thresholds etc.) will be documented. Reduction of procedure-related postoperative complications, particular pulmonic complications in comparison to thoracotomy: Duration of mechanical ventilation Occurrence of pulmonary ventilation disorders: Atelectasis Pleural effusion Pneumothorax Postoperative pain obtained by visual analog pain scale | 7 days | 
| Adverse events | Adverse events will be documented | 12 months | 
| Overall survival | Overall survival will be documented as in the usual clinical routine. | 12 months | 
| Improvement of ejection mechanism | The acute and long-term effects of left-ventricular epimyocardial lead implantation/stimulation obtained by transthoracic echocardiography 1: Ejection fraction in percent, pre- and postoperative | 12 months | 
| Improvement of ventricle coordination | The acute and long-term effects of left-ventricular epimyocardial lead implantation/stimulation obtained by transthoracic echocardiography 2: Inter- and intraventricular delay in miliseconds, pre- and postoperative | 12 months | 
| Risk reduction of endocarditis in dialysis/infected patients | As compared to the literature | 12 months |