Apical closure device for transapical valve procedures.
OBJECTIVE
Transapical transcatheter valve procedures are performed through a left minithoracotomy and require apical sutures to seal the apical access site. The use of large-calibre devices compromises any attempt to fully perform the procedure with a thoracoscopic approach or percutaneously. We report our preliminary experience in animals with a new sutureless self-expandable apical occluder, engineered to perform transapical access site closure in a minimally invasive setting with large-size introducer sheaths.


METHODS
The apical occluder with extendable waist was implanted in six young pigs during an acute animal study. Under general anaesthesia, animals (mean weight: 62 ± 8 kg) received full heparinization (heparin: 100 UI/kg; activated clotting time above 250 s). Through a median sternotomy, a 21-Fr Certitude™ introducer sheath (outer diameter: 25 Fr) was placed over the wire into the cardiac apex. The delivery catheter carrying the constrained apical plug was inserted into the sheath and deployed under fluoroscopic control, whereas the Certitude™ was retrieved. After protamine infusion, we observed and recorded the 1-h bleeding with standard haemodynamic parameters. Animals were sacrificed, and hearts analysed.


RESULTS
Six apical closure devices were successfully introduced and deployed in six pig hearts through large-size apical sheaths at first attempt. In all animals, the plugs guaranteed immediate apical sealing and traces of blood were collected in the pericardium during the 1-h observational period (mean of 16 ± 3.4 ml of blood loss per animal). Haemodynamic parameters remained stable during the entire study period and no plug dislodgement was detected with normal systemic blood pressure (mean arterial mean blood pressure: 65 ± 7 mmHg). Post-mortem analysis confirmed the full deployment and good fixation of all plugs, without macroscopic damages to the surrounding myocardium.


CONCLUSIONS
This sutureless self-expandable apical occluder is a simple device capable of sealing large-size apical access sites (20-35 Fr) in an acute animal study. This approach is a step further towards less invasive transapical valve procedures in the clinical setting, and further animal tests will be performed to confirm the long-term efficacy and safety of this device.
Cardiac Surgery Unit, Cardiocentro Ticino, Lugano, Switzerland Cardiovascular Research Unit, University of Lausanne, Lausanne, Switzerland enricoferrari@bluewin.ch.
Enrico
E
Ferrari
Cardiovascular Research Unit, University of Lausanne, Lausanne, Switzerland.
Denis
D
Berdajs
Cardiac Surgery Unit, University of Lausanne, Lausanne, Switzerland.
Piergiorgio
P
Tozzi
Cardiac Surgery Unit, University of Lausanne, Lausanne, Switzerland.
Giuseppe
G
Siniscalchi
Cardiovascular Research Unit, University of Lausanne, Lausanne, Switzerland.
Ludwig K
LK
von Segesser
D000818:Animals; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D004195:Disease Models, Animal; D004867:Equipment Design; D005260:Female; D005471:Fluoroscopy; D006350:Heart Valve Prosthesis; D013552:Swine; D013906:Thoracoscopy; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation*
Closure device; Percutaneous heart procedures; Transapical valve replacement; Transcatheter aortic valve replacement