Jacek Baranowski

Efficacy and safety of the Lotus Valve System for treatment of patients with severe aortic valve stenosis and intermediate surgical risk: Results from the Nordic Lotus-TAVR registry

BACKGROUND Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile. METHODS AND RESULTS The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N=154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N=79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth <4mm and a device/annulus ratio<1.05. CONCLUSIONS The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients.

Echo-guided presentation of the aortic valve minimises contrast exposure in transcatheter valve recipients

Objectives: We have developed a method using transthoracic echocardiography in establishing optimal visualization of the aortic root, to reduce the amount of contrast medium used in each patient. Background: During transcatheter aortic valve implantation, it is necessary to obtain an optimal fluoroscopic projection for deployment of the valve showing the aortic ostium with the three cusps aligned in the beam direction. This may require repeat aortic root angiograms at this stage of the procedure with a high amount of contrast medium with a risk of detrimental influence on renal function. Methods: We studied the conventional way and an echo guided way to optimize visualisation of the aortic root. Echocardiography was used initially allowing easier alignment of the image intensifier with the transducers direction. Results: Contrast volumes, radiation/fluoroscopy exposure times, and postoperative creatinine levels were significantly less in patients having the echo‐guided orientation of the optimal fluoroscopic angles compared with patients treated with the conventional approach. Conclusion: We present a user‐friendly echo‐guided method to facilitate fluoroscopy adjustment during transcatheter aortic valve implantation. In our series, the amounts of contrast medium and radiation have been significantly reduced, with a concomitant reduction in detrimental effects on renal function in the early postoperative phase.

Can predilatation in transcatheter aortic valve implantation be omitted? - a prospective randomized study

BackgroundThe use of a balloon expandable stent valve includes balloon predilatation of the aortic stenosis before valve deployment. The aim of the study was to see whether or not balloon predilatation is necessary in transcatheter aortic valve replacement (TAVI).MethodsSixty consecutive TAVI patients were randomized to the standard procedure or to a protocol where balloon predilatation was omitted.ResultsThere were no significant differences between the groups regarding early hemodynamic results or complication rates.ConclusionsTAVI can be performed safely without balloon predilatation and with the same early results as achieved with the standard procedure including balloon predilatation. The reduction in the number of pacing periods required may be beneficial for the patient.

Transvenous Implantation of a Stent Valve for Calcified Native Mitral Stenosis.

We used a modified combination of the transseptal and transapical methods to facilitate the controlled delivery and use of a stent valve in a patient with calcified native mitral stenosis. A loop from the right femoral vein passing transseptally and then through the apex of the left ventricle was created, enabling highly controlled positioning and deployment of the stent valve.

Endovascular stenting of an outflow graft thrombosis in a continuous-flow left ventricular assist device.

We report the endovascular stenting of an outflow tract thrombosis in a left ventricular assist device in a patient with relative contraindications to sternotomy and pump exchange. This report highlights the importance of simultaneous prevention of stroke using filter devices in the common carotid arteries.

Left Atrial Pressure Monitoring With an Implantable Wireless Pressure Sensor Following Implantation of a Left Ventricular Assist Device.

After implantation of a continuous-flow left ventricular assist device (LVAD), left atrial pressure (LAP) monitoring allows for the precise management of intravascular volume, inotropic therapy, and pump speed. In this case series of 4 LVAD recipients, we report the first clinical use of this wireless pressure sensor for the long-term monitoring of LAP during LVAD support. A wireless microelectromechanical system pressure sensor (Titan, ISS Inc., Ypsilanti, MI) was placed in the left atrium in four patients at the time of LVAD implantation. Titan sensor LAP was measured in all four patients on the intensive care unit and in three patients at home. Ramped speed tests were performed using LAP and echocardiography in three patients. The left ventricular end-diastolic diameter (cm), flow (L/min), power consumption (W), and blood pressure (mm Hg) were measured at each step. Measurements were performed over 36, 84, 137, and 180 days, respectively. The three discharged patients had equipment at home and were able to perform daily recordings. There were significant correlations between sensor pressure and pump speed, LV and LA size and pulmonary capillary wedge pressure, respectively (r = 0.92–0.99, p < 0.05). There was no device failure, and there were no adverse consequences of its use.

A Simplified Protocol for Transcatheter Aortic Valve Implantationthat Reduces Procedure-Related Risk

Objectives: Transcatheter Aortic Valve Implantation is now a well-established procedure and continuous development has improved the technique. The object of this paper is to describe the successive steps taken at our department to improve our protocol, resulting in a more effective and patient-safe procedure. Design: An echo-guided method for aortic cusp alignment was used in 229 patients. In 139 patients pre-dilatation was excluded from the protocol. In the last 47 of the patients we exchanged the stiff guide-wire in the left ventricle with a soft wire for valve placement. Results: There was a significant decrease in the use of contrast medium during the period with 90% of patients receiving less than 50 ml contrast and 35% no contrast at all. In more than half the patients we only used rapid pacing in association with deployment of the stent valve. We had six cases ofpericardial bleeding due to penetration of the stiff guide wire through the left ventricular (LV) wall. This complication was avoided in all subsequent patients where we exchanged the stiff catheter to a soft guidewire in the ascending aorta before introduction of the wire and stent valve into the LV. Conclusions: We have successively modified our standard protocol for implantation of a balloon-expandable transcatheter aortic valve. This has simplified the procedure and reduced the risk for certain procedure-related complications.

Surgical management of outflow tract obstruction after transapical mitral valve implantation

Left ventricular outflow tract (LVOT) obstruction due to systolic anterior motion of the anterior mitral valve leaflet (AML) is a known complication after mitral valve repair or transfemoral/transapical mitral valve implantation (TMVI). We present a patient with a previous mitral valve repair who developed LVOT obstruction after TMVI in whom the AML was surgically resected using a transaortic approach.

An Implantable Pressure Sensor for Long-term Wireless Monitoring of Cardiac Function -First Study in Man

Background: Heart failure is a huge health problem. The possibility of long-term monitoring heart function more accurately in these patients has gained increasing interest. The primary aim of this study was to see if a wireless pressure sensor can be safely implanted to give accurate and reproducible long-term intracardiac pressure recordings. Another aim was to see if there are any adverse effects connected with the implant. A control group was included for comparison of clinical data. Methods: Forty patients with heart failure, 31 scheduled for open heart surgery and 9 for transcatheter aortic valve replacement (TAVR) were included to test the safety and feasibility of the Titan™ pressure sensor. The patients were randomized to the implant or control group. Findings: Initial sensor measurements showed very good correlation with reference pressure values from a fluid-filled catheter, and there was no need for calibration of the sensor. At the 6-month follow-up 11 patients had been wearing the implant for >1 year with a median time of 560 days. Ten of these had adequate sensor function. Compared to the control group there was no difference in adverse clinical events and the overall number of complications was low. Conclusions: This first study in man on a new implantable wireless hemodynamic monitor showed favorable results regarding our primary endpoints; accuracy of recordings over time and safety profile. The technology has great potential for monitoring at home since it is easy to use in the out-patient setting.

Massive Air Embolism During MitraClip Insertion

This case describes massive air embolism occurring a MitraClip procedure. This most likely occurred when the guide catheter was against the left atrial wall, resulting in external air entrainment. There was air embolism to the right coronary artery causing acute myocardial ischemia and ventricular fibrillation. The patient was successfully rescued and recovered. She underwent a successful MitraClip procedure subsequently.