Piotr Kałmucki

3D heart model printing for preparation of percutaneous structural interventions: description of the technology and case report

BACKGROUND Structural heart disease, including valvular disease as well as congenital defects, causes important alterations in heart anatomy. As a result, individualised planning for both surgical and percutaneous procedures is crucial for procedural optimisation. Three dimensional (3D) rapid prototyping techniques are being utilised to aid operators in planning structural heart procedures. AIM We intend to provide a description of 3D printing as a clinically applicable heart modelling technology for the planning of percutaneous structural heart procedures as well as to report our first clinical use of a 3D printed patient-specific heart model in preparation for a percutaneous mitral annuloplasty using the Mitralign percutaneous annuloplasty system. METHODS Retrospectively gated, contrast enhanced, multi-slice computed tomography (MSCT) scans were obtained. MSCT DICOM data was analysed using software that creates 3D surface files of the blood volume of specific regions of interest in the heart. The surface files are rendered using a software package that creates a solid model that can be printed using commercially available stereolithography machines. RESULTS The technique of direct percutaneous mitral annuloplasty requires advancement of a guiding catheter through the aorta, into the left ventricle, and requires the positioning of the tip of the catheter between the papillary muscles in close proximity to the mitral annulus. The 3D heart model was used to create a procedural plan to optimise potential device implantation. The size of the deflectable guiding catheter was selected on the basis of the patients heart model. Target locations for annulus crossing wires were evaluated pre-procedurally using the individual patients 3D heart model. In addition, the ability to position the Bident Catheter at the appropriate locations under the mitral annulus as well as the manoeuvrability between the papillary muscles were analysed on the heart model, enabling safe completion of the procedure, which resulted in a significant reduction in mitral regurgitation. CONCLUSIONS 3D printing is a helpful tool in individualised planning for percutaneous structural interventions. Future studies are warranted to assess its role in preparing for percutaneous and surgical heart procedures.

Percutaneous direct mitral annuloplasty using the Mitralign Bident™ system: description of the method and a case report

BACKGROUND Functional mitral regurgitation (FMR) is known to contribute to a poor prognosis in patients with heart failure (HF). Current guidelines do not recommend cardiac surgery in patients with FMR and impaired ejection fraction due to the high procedural risk. Percutaneous techniques aimed at mitral valve repair may constitute an alternative to currently used routine medical treatment. AIM To provide a description of a novel percutaneous suture-based technique of direct mitral annuloplasty using the Mitralign Bident system, as well as report our first case successfully treated with this method. METHODS A deflectable guiding catheter is advanced via the femoral route across the aortic valve to the posterior wall of the ventricle. A nested deflectable catheter is advanced through the guide toward the mitral annulus that allows the advancement of an insulated radiofrequency wire to cross the annulus. The wire is directed across the annulus in a target area that is 2-5 mm from the base of the leaflet into the annulus, as assessed by real-time 3D transoesophageal echocardiography. After placement of the first wire, another wire is positioned using a duel lumen bident delivery catheter, which provides a predetermined separation between wires (i.e. 14, 17 or 21 mm). Each wire provides a guide rail for implantation of sutured pledget implants within the annulus. Two pairs of pledgets are implanted, one pair in each of the P1 and P3 scallop regions of the posterior mitral annulus. A dedicated plication lock device is used to provide a means for plication of the annulus within each pair of the pledgets, and to retain the plication by delivering a suture locking implant. The plications result in improved leaflet coaptation and a reduction of the regurgitant orifice area. RESULTS A 60-year-old female with diagnosed dilated cardiomyopathy, concomitant FMR class III and congestive HF was successfully treated with the Mitralign Bident system. Two pairs of pledgets were implanted resulting in an improvement of transoesophageal echocardiographic parameters, including proximal isovelocity surface area radius (0.7 cm to 0.4 cm), effective regurgitant orfice area (0.3 cm² to 0.1 cm²) and mitral regurgitant volume (49 mL to 10 mL). CONCLUSIONS Percutaneous mitral annuloplasty with the Mitralign Bident system is feasible. Future clinical trials are needed to assess its safety and efficacy.

Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial

Objective Functional (or secondary) mitral regurgitation (FMR) is associated with greater morbidity and worse outcomes in patients with congestive heart failure (CHF) and cardiomyopathy. The Carillon® Mitral Contour System® is a coronary sinus-based percutaneous therapy to reduce FMR. We evaluated the safety and efficacy of a modified version of the Carillon device in the treatment of patients with cardiomyopathy and FMR. Methods 36 patients with CHF, depressed left ventricular function (ejection fraction <40%) and at least moderate FMR underwent the Carillon device implant. Results There was 1 major adverse event within 30 days—a death (not device related)—occurring 17 days after the implant. Reductions in FMR and improvements in functional class and 6 min walk tests were seen, similar to prior studies. Device fractures in the high strain region of the proximal anchor (seen in prior studies) were not seen in this study. Conclusions The modified Carillon device was associated with improvements in clinical and echocardiographic parameters in treating patients with FMR, while successfully addressing the issue of anchor fracture. This version of the Carillon device will be used in a blinded randomised trial of symptomatic patients with FMR.

Cardiac resynchronisation therapy after percutaneous trans-coronary-venous mitral annuloplasty

We present a case of a 45-year-old man with symptomatic heart failure and ischaemic functional mitral regurgitation (FMR), who underwent a successful percutaneous trans-coronary venous mitral annuloplasty with the Carillon system. The procedure resulted in clinical improvement as well as in a decrease in the degree of MR as assessed by echocardiography. Fifteen months later, the patient underwent cardiac resynchronisation (CRT) device implantation, resulting in a further improvement in echocardiographic measures of FMR. This case not only confirms the feasibility of CRT after percutaneous trans-coronary-venous mitral annuloplasty, but also suggests a possible synergistic effect of both therapies, warranting future clinical trials.

B-type natriuretic peptide in patients after percutaneous trans-coronary-sinus mitral annuloplasty

BACKGROUND AND AIM Functional mitral regurgitation (MR) remains a significant clinical problem. Surgical valve repair carries a high procedural risk. Thus, percutaneous techniques are under development. One of the most advanced devices for percutaneous mitral annuloplasty (PTMA) is the Carillon™ device. B-type natriuretic peptide (BNP) is a marker of haemodynamic status in heart failure patients. So far, its usefulness in patients after PTMA is unknown. METHODS Thirteen consecutive patients after successful implantation of the Carillon™ device were enrolled. PTMA was achieved through the coronary sinus in order to improve leaflet coaptation. Before PTMA, immediately after, and at one month follow-up, transthoracic echocardiography was performed. Furthermore, plasma BNP levels, the six-minute walk test (6MWT) and the Naughton treadmill exercise test were evaluated before PTMA and after one month. RESULTS In patients after successful PTMA, significant improvement in echocardiographic parameters was maintained at one-month follow-up: vena contracta (0.31 ± 0.03 vs. 0.64 ± 0.03 cm, p < 0.05), effective regurgitant orifice area (0.2 ± 0.02 vs. 0.32 ± 0.05 cm², p < 0.05), MR jet area/left atrial area (32.33 ± 1.98 vs. 47.06 ± 2.3%,p < 0.05) and regurgitant volume (27.84 ± 2.17 vs. 45.25 ± 7.47 mL, p < 0.05). Both the duration of the exercise test (4.3 ± 0.45 vs. 3.12 ± 0.18 min, p < 0.05) and 6MWT (320 ± 29.63 vs. 295.2 ± 13.4 m, p < 0.05) improved. Furthermore, improvement of the NYHA class was observed. Despite that, mean BNP levels remained unchanged (405.3 ± 133.9 vs. 596.5 ± 245.2 pg/mL, p = 0.191; after and before the procedure, respectively). In some patients with device located above the annulus level, an increase in BNP leve ls was observed. CONCLUSIONS BNP seems to be useless for the assessment of patients after PTMA. This may be related to mechanical stress on the annulus and atrial wall caused by the device itself.

The bipolar ablation of refractory typical atrial flutter with CARTO 3 Confidense system

The typical atrial flutter is a reentrant arrhythmia with critical isthmus between tricuspid valve and inferior vena cava. The main target of ablation is to create a bidirectional block in the cavotricuspid isthmus. There are several anatomical variants which can create the obstacle to achieve successful ablation, namely the long isthmus, its shape (straight, convex, or pouch like), prominent Eustachian ridge or overdeveloped Chiari’s network. The bipolar ablation can result in higher transmurality than unipolar ablation, however there are only a few published cases and there are no dedicated systems. We report on the 59 year old female with incessant atrial flutter with rapid ventricular response who developed cardiomyopathy. She previously underwent three unsuccessful RF ablations in two different EP centers. Long applications up to 50 W with the use of 8 mm and irrigated tip electrodes were only transiently successful. At this stage the patient was qualified for RF bipolar ablation. As it is off-labelled use of standard RF generator and ablation electrodes the procedure obtained an individual permission from Local Ethics Committee and patient provided a written informed consent before procedure. Ablation was performed under general anaesthesia as previous ablations were painful. The 10 pole electrodes were positioned in the coronary sinus and the lateral part of right atrium. The high density map has been created using THERMOCOOLR SMARTTOUCH Catheter connected to CARTO 3 system with Confidense module (Biosense-Webster, Inc.). The entrainment pacing and propagation map confirmed cavotricuspid isthmus involvement in the flutter. The isthmus was meticulously visualized and measured. The slow conduction through the middle part was identified (Figure 1A). Initially, standard 180 s linear application (40 W) was delivered without success. Thereafter the THERMOCOOLR SMARTTOUCH Catheter was positioned on the middle part of the isthmus. The 7F 4 mm Celsius electrode (Biosense-Webster, Inc.) was introduced to the right atrium and connected to the LabSystem Pro (Boston Scientific) and Stockert generator in order to record the most distal atrial potential of the isthmus and impedance. This was to avoid going to deeply into IVC and performing ablation in the vein. After checking the position of electrodes on fluoroscopy in two projections, Celsius electrode was connected with indifferent electrode receptacle of the RF generator using a custom-made connector (Figure 1B). 40 W application was started resulting in flutter interruption in 10 s with bidirectional block. The application was continued for 90 s slowly dragging the active electrode to reach the other side of the isthmus precisely monitoring the impedance which decreased from 147 to 141 X. After 30 min after ablation there was bidirectional block with line of double potentials. The patient was discharged and followed for 3 months without recurrence of atrial flutter.

Percutaneous Trans‐Coronary Venous Mitral Annuloplasty in Patients With Functional Mitral Regurgitation: Analysis of Poznan Carillon Registry Data

OBJECTIVES The purpose of our study is to verify, whether percutaneous mitral annuloplasty results in reverse remodeling in patients with functional mitral regurgitation (FMR) and impaired ejection fraction (EF) and to investigate which echo parameters may help in prediction of the efficacy of the procedure. BACKGROUND FMR exacerbates left ventricular (LV) dilatation and contributes to both LV remodeling and heart failure. METHODS We analyzed baseline and 1 month follow-up data in 22 consecutive patients with FMR, who underwent successful percutaneous trans-coronary venous mitral annuloplasty with the Carillon device. RESULTS Significant reduction of FMR echo parameters, including vena contracta (VC), effective regurgitant orifice area (EROA), and regurgitant volume (RV) were observed and maintained throughout 1 month follow up and did not correlate with baseline annular, LV or with the left atrial diameters. Baseline mitral tenting area correlated negatively with the relative improvement (% difference) of EROA (r = -0.5898) and RV (r = -0.4363), but not with VC (r = 0.1341). In addition, increased EF as well as a significant reduction in left ventricular diameters were noted. The increase in EF negatively correlated with the change in EROA (r = -0.50058), PISA (r = -0.5327), and RV (r = -0.5457). Baseline mitral tenting area significantly correlated with the 1 month change in EF (r = 0.5946) and stroke volume (r = 0.6913). CONCLUSIONS The improvement of FMR after treatment with the Carillon device is associated with LV reverse remodeling and an increase in systolic performance, that correlates with the reduction in mitral regurgitation, being not dependent on baseline heart diameters. Mitral tenting area seems to be an important parameter in prediction of benefit from percutaneous mitral annuloplasty.

Bipolar irrigated radiofrequency ablation of resistant ventricular tachycardia with a septal intramural origin: the initial experience and a description of the method

Bipolar radiofrequency (RF) ablation is effective in treatment of ventricular tachycardia originating from thick interventricular septum. The RF generator and CARTO system can be used to precisely and safely perform ablation. Standard ablation catheter can be used with indifferent ablation electrode connected to the electrode receptacle in RF generator with custom‐made cable.

THE EFFICACY OF PERCUTANEOUS TRANS-VENOUS MITRAL ANNULOPLASTY FOR THE TREATMENT OF FUNCTIONAL MITRAL REGURGITATION: PREDICTIVE VALUE OF ECHOCARDIOGRAPHIC PARAMETERS

Implantation of Carillon device into the coronary venous system was shown to result in the reduction in functional mitral regurgitation (FMR), but it is not clear which patient would benefit the most. We investigated which echo parameters may help in prediction of the efficacy of percutaneous mitral

Stent loss in the radial artery - surgical vs. interventional approach - report of two cases

Stent loss during coronary angioplasty is a complication that can be managed in various manners; however, transradial access limits the options available. We describe two coronary interventions complicated by stent dislodgement, initially managed by pulling the stent back to the radial artery. Both stents were unwillingly lost on different levels in radial arteries. The first case was managed with a direct radial artery cut-down because distal location made it a quick and straightforward procedure. In the second case a partially deployed stent was lost in the proximal part of the radial artery. It was rewired, deployed, and post-dilated with a larger balloon. This enabled continuation of the procedure using the same access. Both cases were asymptomatic during 24 months of follow-up. It is crucial to avoid leaving artificial bodies in arteries supplying vital organs because stent-related thrombosis or stenosis may seriously compromise blood flow. Removing the stent via the introducer sheath should be considered the optimal treatment. Unfortunately it is common that a partially expanded stent will not pass through the sheath. The superficial location of the distal radial artery segment facilitates surgical cut-down with local anaesthesia. When dislodgement occurs in deeper segments of the radial artery, the benefits from cut-down seem to be less because the procedure might take more time and be more difficult – as in the presented case in which we decided to rewire and fully expand the stent in situ. Retrieval of the stent at all costs might have led to further complications; hence stent deployment may be a good alternative to retrieval in such cases.