Usability and accuracy of two different aortic annulus sizing software programs in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Semi-automated software is essential for planning and prosthesis selection prior transcatheter aortic valve replacement (TAVR). Reliable data on the usability of software programs for planning a TAVR is missing. The aim of this study was to compare software programs 'Valve Assist 2' (GE Healthcare) and 3mensio 'Structural Heart' (Pie Medical Imaging) regarding usability and accuracy of prosthesis size selection in program-inexperienced users. METHODS: Thirty-one participants (n = 31) were recruited and divided into program-inexperienced users (beginners) (n = 22) and experts (n = 9). After software training, beginners evaluated 3 patient cases in 129 measurements (n = 129) using either Valve Assist 2 (n = 11) or Structural Heart (n = 11) on 2 test days (T1, T2). System Usability Scale (SUS) and ISONORM 9241/110-S (ISONORM) questionnaire were used after the test. The valve size selected by each beginner was compared with the valve size selected from expert group. RESULTS: Valve Assist 2 had higher SUS Score: median 78.75 (25th, 75th percentile: 67.50, 85.00) compared to Structural Heart: median 65.00 (25th, 75th percentile: 47.50, 73.75), (p < 0,001, r = 0.557). Also, Valve Assist 2 showed a higher ISONORM score: median 1.05 (25th, 75th percentile: - 0.19, 1.71) compared to Structural Heart with a median 0.05 (25th, 75th percentile: - 0.49, 0.13), (p = 0.036, r = 0.454). Correctly selected valve sizes were stable over time using Valve Assist 2: 72.73% to 69.70% compared to Structural Heart program: 93.94% to 40% (χ2 (1) = 21.10, p < 0.001, φ = 0.579). CONCLUSION: The study shows significant better usability scores for Valve Assist 2 compared to 3mensio Structural Heart in program-inexperienced users.

First successful transcatheter valve-in-valve implantation into a failed mechanical prosthetic aortic valve facilitated by fracturing of the leaflets: a case report.

BACKGROUND: Degenerated and failed bioprosthetic cardiac valves can safely be treated with transcatheter valve-in-valve implantation in patients at high risk for reoperation. So far, non-functional mechanical valves must be treated with a surgical redo. Breaking the carbon leaflets before implanting a transcatheter valve into the remaining ring has never been described before. CASE SUMMARY: Here, we present the case of a 65-year-old male patient with severe heart failure, poor left ventricular function based on a fully immobile disc of his mechanical bileaflet aortic valve implanted 7 years ago. After the heart team declined to reoperate the patient due to his extremely high risk, we considered a transcatheter valve-in-valve implantation as the ultimate treatment approach. After successful interventional cracking of the leaflets in vitro, this approach, together with implanting a balloon-expandable transcatheter aortic valve replacement (TAVR) into the remaining ring, was performed under cerebral protection. The intervention resulted in a fully functional TAVR, improvement of heart function, and early discharge from the hospital. DISCUSSION: This case demonstrates the possibility to implant a transcatheter valve successfully into a non-functional mechanical bileaflet aortic prosthesis after fracturing the carbon discs while the brain is protected by a filter system. Critical steps of the procedure were identified. This new therapeutic approach might be offered to a limited patient cohort who is not eligible for a surgical redo.

Conduction recovery and avoidance of permanent pacing after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe aortic stenosis and high surgical risk. Currently, various prosthesis types are available. Atrioventricular block (AVB) requiring pacemaker (PM) implantation is a typical complication after TAVI. This study investigated the recovery of AV node conduction and mid-term outcome of patients with or without PM implantation after TAVI according to prosthesis type. METHODS: From July 2008 to May 2015, 856 transcatheter heart valves were implanted at our center (age: 80.5±6.1 years; logistic EuroSCORE: 15.4%). These patients were followed up regularly in our outpatient clinic. RESULTS: PM implantation was performed in 16.9% of patients due to severe conduction disturbances, mainly third-degree AVB. The need for PM implantation differed between the various prosthesis types: Medtronic CoreValve (Medtronic Inc., Minneapolis, MN, USA): 22.8% (n=272), Edwards Sapien XT (Edwards Lifesciences, Irvine, CA, USA): 13.0% (n=262), Edwards Sapien 3 (Edwards Lifesciences, Irvine, CA, USA): 16.2% (n=234), Direct Flow Medical (Direct Flow Medical, Santa Rosa, CA, USA): 7.3% (n=41), St. Jude Medical Portico (St. Jude Medical, St. Paul, MN, USA): 15.4% (n=26), Boston Scientific Lotus (Boston Scientific, Marlborough, MA, USA): 21.4% (n=14) and Medtronic Evolut R (Medtronic Inc., Minneapolis, MN, USA): 14.3% (n=7). Kaplan-Meier analysis for all-cause mortality did not reveal any differences between the various prosthesis types. PM implantation rates declined over the years of experience in a stable intervention team; 45% of PM patients showed sufficient AV node conduction after PM reprogramming at our follow-up examination. CONCLUSIONS: Mid-term all-cause survival after TAVI seems to be independent of prosthesis type and PM implantation after TAVI. Intrinsic AV node conduction recovers in a significant proportion of patients. Therefore, regular PM interrogations including reprogramming are required to avoid unnecessary permanent right ventricular stimulation.

Fibrinolytic Treatment after Transient Ischaemic Attack Caused by Prosthetic Mitral Valve Thrombosis.

Prosthetic valve thrombosis is one of the most severe complications after surgical valve replacement. There are many possible presentations: from asymptomatic to life-threatening complications. We report on a 61-year-old female patient with prosthetic replacement of the aortic and mitral valve in the in-house department of cardiac surgery 3 months ago. The patient was suffering from aphasia during 5 minutes in domesticity. After her presentation in the emergency room, the echocardiographic examination revealed a thrombotic formation of the prosthetic mitral valve. At presentation, the anticoagulation was outside the effective range (INR: 1.7). A successful thrombolytic therapy with the plasminogen activator urokinase was begun with complete resolution of the thrombus.

[Pacemaker dependant and/or repetitive ICD therapies. How to solve the dilemma of lead extraction?]. / Schrittmacherabhängigkeit und/oder rezidivierende ICD-Therapien. Wie löst man dieses Problem nach Systemexplantation?

Bridging pacemaker-dependent patients or patients with repetitive ICD therapies after device and lead extraction is often challenging. Temporary pacing by means of an active fixation lead connected to an external reusable permanent pacemaker, or of a subxiphoidally implanted pacemaker with an epicardial lead is a safe option for bridging pacemaker-dependent patients after device and lead explantation. The wearable cardioverter defibrillator (WCD; LifeVest(®)) is a safe and effective tool for patients who need a continuous monitoring and ICD backup after device explantation.

Patient selection criteria and midterm clinical outcome for MitraClip therapy in patients with severe mitral regurgitation and severe congestive heart failure.

AIMS: The implantation of a MitraClip (MC) is a new treatment modality for severe mitral regurgitation (MR) in patients whose condition is inoperable or who are at high conventional operative risk. This study reports the follow-up data of patients implanted with an MC in our heart centre to find selection criteria for this procedure in patients with severe congestive heart failure. METHODS AND RESULTS: This study included 163 implantation procedures in 157 patients between March 2009 and November 2012. The severe MR was caused by functional or organic valve disease. The patients had no surgical treatment option or dramatically increased surgical operative risk due to reduced LVEF or concomitant diseases. Three (2%) implantation procedures were unsuccessful. Eleven (7%) patients died during the first 30 days after MC implantation, and 9 (6%) additional patients died during the first 6 months, both groups mainly due to severe, therapy-resistant end-stage heart failure. The 111 patients who were followed up showed significant improvement in NT-proBNP, LVEF, NYHA class, 6 min walk test, and quality of life. Ten (6%) patients needed conventional heart surgery despite high operative risk due to persistent symptomatic MR after MC implantation. CONCLUSION: The interventional implantation of an MC is a new treatment for severe MR with acceptable periprocedural risk and results in clinical improvement in the majority. Patients with end-stage heart failure and an NT-proBNP value >10 000 pg/mL have a high mortality despite MC implantation, and their treatment should be based on a very individualized decision. Based on this experience, a clinical algorithm for patient selection is proposed.

Rotational angiography for preinterventional imaging in transcatheter aortic valve implantation.

OBJECTIVE: To evaluate the clinical value of 3D rotational angiography, as a tool for imaging and measuring 3D anatomy, coupled with transesophageal echocardiogram (TEE) as preinterventional imaging for transcatheter aortic valve implantation (TAVI) procedures. BACKGROUND: TAVI is a growing field in cardiology. An understanding of the 3D anatomy of the aortic root is crucial for patient selection and for the optimal planning and guidance of such procedures. Current techniques include 3D imaging (with MSCT MRI and 3D TEE) combined with multiplane TEE. Nevertheless, a gold standard of 3D imaging is yet not defined. 3D rotational angiography provides 3D anatomy information in the cathlab. Initially designed for nonmoving anatomical structures, one can adapt the protocol to temporarily minimize the heart anatomy motion during rotational angiography. METHODS: Ninety-nine consecutive patients (61 females, 38 males, age 80.9 ± 5.2 years) with symptomatic aortic stenosis underwent 3D rotational angiography to assess the anatomical suitability of potential TAVI candidates. 3D rotational angiography with a C-Arm (Innova 3100(IQ) , GE Healthcare, Chalfont St Giles, UK) was performed to create the 3D anatomy of the aortic root. Coronary angiography and pelvic vessel angiography were performed during the same examination. Measurements of the aortic annulus and the sinotubular junction were made on the 3D cross-sections and were compared to TEE. Radiation dose to the patient was also monitored. RESULTS: In all 99 patients, 3D rotational angiography was performed successfully with good imaging of the aortic root and measurements of the aortic annulus. In patients scheduled for SAPIEN valve implantation, the distances from the annulus to the coronary ostia were also measured. Of 99 patients, 80 subsequently underwent successful implantation. There is a good correlation to the TEE in the measured aortic annulus (22.13 ± 2.09 mm in rotational angio, 21.58 ± 2.09 mm TEE, Spearman r = 0.88, 95% IC [0.83;0.92], P < 0.0001) and sinotubular junction (26.19 ± 2.71 mm in rotational angio, 26.22 ± 2.73 mm TEE, Spearman r = 0.83, 95% IC [0.75;0.88], P < 0.0001). The effective dose is a fraction of the X-ray dose required for multi-slice computed tomography. CONCLUSION: Given that this technology is available in the cathlab at reasonable dose levels, 3D rotational angiography has proven to be a suitable preinterventional 3D imaging modality for TAVI procedures. Together, the raw angiographic data and the reconstructed 3D volume provide all the necessary anatomical information necessary for this procedure, including the measurements.

[Acute coronary syndrome: ST-segment elevation infarct]. / Das Akute Koronarsyndrom: ST-Hebungsinfarkt.

Management of acute myocardial infarction in patients presenting with ST-segment elevation has evolved considerably over the past decades. In this review, we will limit the discussion to STEMI, and describe some recent developments and new insights into the evidence base of various therapeutic options. We will address the contemporary antithrombotic approach to treatment of this disorder. The controversy regarding optimal treatment of ACS, whether invasive or conservative, is discussed. This seems all the mandatory more as many study populations are not directly comparable, and some therapies are nowhere at hand. Progressively important cost-benefit considerations are another aspect that makes the assessment of the evidence claimed difficult.