Short-term outcome after transcatheter aortic valve replacement with a novel balloon-expandable valve.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) has been expanding rapidly with numerous transcatheter heart valve (THV) systems currently available. The Myval balloon-expandable (BE) valve (Meril Life Sciences Pvt. Ltd., India) is a novel THV system indicated for the treatment of patients with severe aortic stenosis. The primary objective of this study is to assess the safety and performance of the Myval BE valve. METHODS: In this prospective single-centre study, 120 consecutive patients who underwent TAVR with the Myval BE valve were included. Clinical outcomes were evaluated at 30 days and 6 months using Valve Academic Research Consortium­2 criteria. All-cause mortality, stroke, acute kidney injury, major vascular complications, moderate or severe paravalvular leakage (PVL) and need for a permanent pacemaker implantation (PPI) were investigated. RESULTS: At 6­month follow-up, all-cause death and cardiac death were seen in 5.8% and 0.8% of the patients respectively. Periprocedural stroke and need for PPI were both seen in 3.3% of the patients. Access-site-related vascular and bleeding complications were absent. Improved valve haemodynamics and no moderate to severe PVL could be seen at 30 days. An intermediate valve size was selected in 51% of the patients. CONCLUSIONS: The Myval BE valve demonstrates improved valve haemodynamics, absence of moderate to severe PVL and good safety outcomes at 6­month follow-up with low cardiac death rate and acceptable rates of permanent pacemaker implantation and periprocedural stroke. Future randomised controlled trials will further establish the clinical utility of the Myval BE valve.

Decision making in treatment of symptomatic severe aortic stenosis: a survey study in Dutch heart centres.

AIM: To provide insight into the basic characteristics of decision making in the treatment of symptomatic severe aortic stenosis (SSAS) in Dutch heart centres with specific emphasis on the evaluation of frailty, cognition, nutritional status and physical functioning/functionality in (instrumental) activities of daily living [(I)ADL]. METHODS: A questionnaire was used that is based on the European and American guidelines for SSAS treatment. The survey was administered to physicians and non-physicians in Dutch heart centres involved in the decision-making pathway for SSAS treatment. RESULTS: All 16 Dutch heart centres participated. Before a patient case is discussed by the heart team, heart centres rarely request data from the referring hospital regarding patients' functionality (n = 5), frailty scores (n = 0) and geriatric consultation (n = 1) as a standard procedure. Most heart centres 'often to always' do their own screening for frailty (n = 10), cognition/mood (n = 9), nutritional status (n = 10) and physical functioning/functionality in (I)ADL (n = 10). During heart team meetings data are 'sometimes to regularly' available regarding frailty (n = 5), cognition/mood (n = 11), nutritional status (n = 8) and physical functioning/functionality in (I)ADL (n = 10). After assessment in the outpatient clinic patient cases are re-discussed 'sometimes to regularly' in heart team meetings (n = 10). CONCLUSIONS: Dutch heart centres make an effort to evaluate frailty, cognition, nutritional status and physical functioning/functionality in (I)ADL for decision making regarding SSAS treatment. However, these patient data are not routinely requested from the referring hospital and are not always available for heart team meetings. Incorporation of these important data in a structured manner early in the decision-making process may provide additional useful information for decision making in the heart team meeting.

COVID-19-mediated patient delay caused increased total ischaemic time in ST-segment elevation myocardial infarction.

BACKGROUND: The current study aimed to evaluate changes in treatment delay and outcome for ST-segment elevation myocardial infarction (STEMI) in the Netherlands during the first coronavirus disease 2019 (COVID-19) outbreak, thereby comparing regions with a high and low COVID-19 hospitalisation rate. METHODS: Clinical characteristics, STEMI timing variables, 30-day all-cause mortality and cardiovascular complications of all consecutive patients admitted for STEMI from 1 January to 30 June in 2020 and 2019 to six hospitals performing a high volume of percutaneous coronary interventions were collected retrospectively using data from the Netherlands Heart Registry, hospital records and ambulance report forms. Patient delay, pre-hospital delay and door-to-balloon time before and after the outbreak of COVID-19 were compared to the equivalent periods in 2019. RESULTS: A total of 2169 patients were included. During the outbreak median total treatment delay significantly increased (2 h 51 min vs 2 h 32 min; p = 0.043) due to an increased patient delay (1 h 20 min vs 1 h; p = 0.030) with more late presentations > 24 h (1.1% vs 0.3%) in 2020. This increase was particularly evident during the peak phase of COVID-19 in regions with a high COVID-19 hospitalisation rate. During the peak phase door-to-balloon time was shorter (38 min vs 43 min; p = 0.042) than in 2019. All-cause 30-day mortality was comparable in both time frames (7.8% vs 7.3%; p = 0.797). CONCLUSIONS: During the outbreak of COVID-19 patient delay caused an increase in total ischaemic time for STEMI, with a more pronounced delay in high-endemic regions, stressing the importance of good patient education during comparable crisis situations.

Percutaneous mitral valve repair: the necessity to redefine secondary mitral regurgitation.

Interest in percutaneous mitral valve repair has increased during recent years. This is mainly driven by the significant number of patients being declined for mitral valve surgery because of a high risk of surgery-related complications or death. In this subset of patients, percutaneous edge-to-edge repair using the MitraClip device (Abbott, Menlo Park, CA, USA) has become an established treatment option, proven to be safe, efficient and associated with improved functional status. In contrast to primary mitral regurgitation (MR), clinical outcomes after mitral valve surgery appear to be less favourable as regards secondary MR due to heart failure. In the MITRA-FR and COAPT trials, patients with moderate to severe and severe secondary MR with reduced left ventricular function received either medical treatment (control group) or MitraClip implantation plus medical treatment (device group). Results were conflicting, with only the COAPT trial showing better clinical outcomes in the device group. However, both trials are now seen as complementary and provide useful information especially regarding patient selection for MitraClip therapy. The goal of this review is to delineate which subset of patients with secondary MR will potentially benefit from percutaneous mitral valve repair.

The rationale of using cerebral embolic protection devices during transcatheter aortic valve implantation.

Aortic valve stenosis is one of the most common valvular abnormalities, which can manifest as angina, syncope, dyspnoea and sudden cardiac death. Transcatheter aortic valve implantation (TAVI) has been introduced as an alternative to surgical valve replacement in patients with severe aortic valve stenosis, resulting in less morbidity, shorter time to recovery and similar mortality rates. Progress in this field has reduced complication rates. However, the incidence of peri-procedural stroke remains relatively high (around 4%). To fully utilise the potential of TAVI, cerebral embolic protection devices (CEPD) have been developed and introduced. In this position paper, we aim to summarise the available data on several CEPD.

Current MitraClip experience, safety and feasibility in the Netherlands.

PURPOSE: Data on MitraClip procedural safety and efficacy in the Netherlands are scarce. We aim to provide an overview of the Dutch MitraClip experience. METHODS: We pooled anonymised demographic and procedural data of 1151 consecutive MitraClip patients, from 13 Dutch hospitals. Data was collected by product specialists in collaboration with local operators. Effect on mitral regurgitation was intra-procedurally assessed by transoesophageal echocardiography. Technical success and device success were defined according to modified definitions of the Mitral Valve Academic Research Consortium (MVARC). RESULTS: Median age was 76 (interquartile range 69-82) years and 59% were males. Patients presented with ≥moderate mitral regurgitation and a predominance of functional mitral regurgitation (72%). Overall, 611 (53%) patients were treated with one Clip, 486 (42%) with ≥2 Clips and 54 (5%) received no Clip. The number of patients with ≥2 Clips increased from 22% in 2009 to 52% in 2016. Device success and technical success were 91 and 95%, respectively, and were consistent over the years. Significant reduction of mitral regurgitation by MitraClip was achieved in 94% of patients and was observed more often in patients with functional mitral regurgitation (95% vs. 91%, p = 0.025). Device time declined from 145 min in 2009 to 55 min in 2016. CONCLUSION: MitraClip experience in the Netherlands is growing with excellent technical success and device success. Over the years, device time decreased and more patients were treated with ≥2 Clips.

A complicated transseptal puncture during Mitraclip procedure: saved by 3D-TEE.

We report a case where real-time three-dimensional transoesophageal echocardiography (3D-TEE) was able to detect a complicated transseptal puncture during a Mitraclip procedure which was not seen on the two-dimensional TEE (2D-TEE) images. This case demonstrates the incremental value of 3D-TEE during transseptal puncture.

Percutaneous mitral valve repair using the edge-to-edge technique in a high-risk population.

Background. Percutaneous mitral valve (MV) repair using the edge-to-edge clip technique might be an alternative for patients with significant mitral regurgitation (MR) and an unacceptably high risk for operative repair or replacement. We report the short-term safety and efficacy of this new technique in a high-risk population.Methods. All consecutive high-risk patients who underwent percutaneous MV repair with the Mitraclip(®) between January and August 2009 were included. All complications related to the procedure were reported. Transthoracic echocardiography for MR grading and right ventricular systolic pressure (RVSP) measurement were performed before, and at three and 30 days after the procedure. Differences in NYHA functional class and quality of life (QoL) index were reported. Results. Nine patients were enrolled (78% male, age 75.9±9.0 years, logistic EuroSCORE 33.8±9.0%). One patient developed inguinal bleeding. In one patient partial clip detachment occurred, a second clip was placed successfully. The MR grade before repair was ≥3 in 100%, one month after repair a reduction in MR grade to ≤2 was present in 78% (p=0.001). RVSP decreased from 43.9±12.1 to 31.6±11.7 mmHg (p=0.009), NYHA functional class improved from median 3 (range 3 to 4) to 2 (range 1 to 4) (p=0.04), and QoL index improved from 62.9±16.3 to 49.9±30.7 (p=0.12). Conclusion. In high-risk patients, transcatheter MV repair seems to be safe and a reduction in MR can be achieved in most patients, resulting in a short-term improvement of functional capacity and QoL. (Neth Heart J 2010;18:437-43.).

Three-dimensional transoesophageal echocardiography in a patient undergoing percutaneous mitral valve repair using the edge-to-edge clip technique.

We report a case of percutaneous mitral valve repair, using the Mitraclip device, in which we show that application of real-time three-dimensional transoesophageal echocardiography (3D-TEE) is extremely helpful for the guidance of this procedure. Because of its excellent visualization capacities, 3D-TEE simplifies the transseptal puncture, the positioning of the clip above the mitral valve orifice, the grasping of the mitral valve leaflets, and the evaluation of the final result. Therefore, we conclude that 3D-TEE has the potential to increase the safety and efficacy of this new technique to treat mitral regurgitation in patients who cannot undergo conventional valve surgery.

New bioabsorbable septal repair implant for percutaneous closure of a patent foramen ovale: short-term results of a single-centre experience.

BACKGROUND: Permanent implants for closure of a patent foramen ovale (PFO) have a number of possible disadvantages including erosions, thrombus formation, and allergic reactions. The incidence of adverse events may be lower using a bioabsorbable device. OBJECTIVE: To evaluate the short-term safety and efficacy of a new bioabsorbable closure device. METHODS: All 35 consecutive patients (21 female, mean age 47.9 +/- 10.8 years), who underwent a percutaneous PFO closure between November 2007 and July 2008, were included. All complications were reported. The efficacy was based on the residual shunting the day after implant and at 1 month follow-up and was graded as minimal, moderate, or severe, using contrast transthoracic echocardiography with the Valsalva manoeuvre. RESULTS: The only in-hospital complication was a surgical device retrieval from the femoral vein. Four patients developed a minimal inguinal haematoma. One day after closure, residual shunting was present in 56% of the patients (minimal 27%, moderate 23% and severe 6%). At 1 month follow-up (n = 33), one patient developed a transient neurological deficit and three patients suffered from paroxysmal atrial fibrillation. A residual shunt at 1 month was present in 45% of the patients (minimal 30%, moderate 12%, and severe 3%). CONCLUSIONS: Percutaneous PFO closure using the bioabsorbable closure device seems to be safe. However, a high rate of residual shunting is present at 1 month follow-up. Long-term follow-up data are necessary to evaluate the efficacy and safety of this device.

Spontaneous coronary artery dissection in the postpartum period.

Spontaneous coronary artery dissection is a very uncommon cause of acute coronary syndrome. It occurs predominantly in young to middle-aged women during or after pregnancy. The aetiology remains uncertain. Possible factors are hormonal changes, haemodynamic stress and changes in autoimmune status. In case of single-vessel dissection and normal blood flow, conservative treatment often leads to complete angiographic resolution. This case report describes the clinical presentation, diagnosis and therapy of spontaneous coronary artery dissection in a 37-year-old woman in the postpartum period. (Neth Heart J 2008;16:412-4.).