Transcatheter closure of patent foramen ovale using the Cocoon occluder: A multicenter retrospective study.

BACKGROUND: The Cocoon patent foramen ovale (PFO) occluder is a new device especially designed for transcatheter closure of PFO. This occluder has some distinctive structural modifications aimed at reducing the risk of major complications of transcatheter PFO closure. In this report we present our initial experience to evaluate the efficacy and safety of the Cocoon PFO occluder in 253 patients who underwent transcatheter PFO closure. METHODS: The study cohort included 253 patients (median age 45 years) with embolic stroke of undetermined source who underwent attempted transcatheter closure of PFO for secondary prevention of paradoxical embolism. Patients were enrolled retrospectively from five sites in Greece and one in Romania between December 2016 and January 2021, and the median follow-up period was 28 months (range 12-48 months). Clinical and laboratory data from each participating center were sent to an electronic registry for evaluation and statistical analysis. RESULTS: The Cocoon PFO occluder was permanently implanted in all patients. At 6 months, complete occlusion of PFO was observed in 251/253 (99.2%) patients. Three (1.2%) patients had a trivial residual shunt. Thrombus formation on the device, which was successfully treated with recombinant tissue plasminogen activator infusion, was observed in one (0.4%) patient. No other complications occurred. During a median follow-up period of 28 months, 3 (1.2%) patients, aged 64-67 years, developed new onset paroxysmal atrial fibrillation. No neurologic events, cardiac erosions, allergic reactions to nickel, or thrombus formation occurred. CONCLUSION: The Cocoon PFO occluder is an effective and safe device that adds to our armamentarium for transcatheter closure of PFO.

Correlation of Clinical Outcomes with the Prominent Indication of Transcatheter Paravalvular Leak Closure: A Multicenter Experience.

BACKGROUND: A paravalvular leak (PVL) is a complication following valve replacement, which may lead to heart failure and hemolysis. The aim of this study is to investigate whether the clinical outcome after transcatheter PVL closure differs according to the prominent indication of the procedure (symptoms of heart failure or hemolysis). METHODS: The data of consecutive patients who had transcatheter treatment for PVL between July 2011 and September 2022 in five Greek centers were analyzed. The primary endpoint was the technical, and clinical success rates with regards to the prominent indication of paravalvular leak closure. The secondary endpoints included the evaluation and comparison of the clinical and technical success in relation to the type of valve that was treated (aortic or mitral) as well as the survival analysis in relation to the closure indication and type of valve that was treated. RESULTS: In total, 60 patients were retrospectively studied (39% men, mean age 69.5 ± 11 years). Regarding the primary outcomes, the technical success in patients mainly suffering from hemolysis was 86.1%, while in those presenting heart failure it was 95.8%, p = 0.387. Furthermore, the clinical success was 72.2% and 87.5% among hemolysis and heart failure patients, respectively, p = 0.210. During the follow-up period, the two-year survival rates were significantly better for patients treated for the aortic valve (78.94%) compared to those in the mitral position (48.78%), p = 0.014. In total, 25 patients died (41.7%) during 24 months of follow-up. CONCLUSIONS: Transcatheter paravalvular leak closure can be performed with high technical and clinical success rates without any difference according to the prominent indication of closure.

Transcatheter closure of paravalvular leak: Multicenter experience and follow-up.

BACKGROUND: Paravalvular leak (PVL) is a common complication following valve replacement, which leads to heart failure and hemolysis. Transcatheter PVL closure has emerged as a reliable alternative with promising results. We quote the combined three-center experience of PVL patients treated percutaneously. METHODS: Consecutive patients treated percutaneously for PVL were retrospectively studied. Procedural characteristics, inhospital, and long-term clinical outcomes were assessed. Technical (successful deployment) and clinical (NYHA and/or hemolysis improvement) success were evaluated. RESULTS: In total, 39 patients treated for PVL in either the aortic (12 patients) or the mitral (27 patients) position were studied. Amplatzer Vascular Plug III was the most commonly used device among the 45 devices totally implanted. Postprocedurally, the rates of at least moderate PVL (87.5% preprocedurally vs 10.5% at discharge) and functional status (mean NYHA class 2.8 ± 0.7 on admission vs 1.5 ± 0.8 at follow-up) were statistically significantly improved. Total population technical success rate was 89.7%, being comparable between patients treated for mitral or aortic valve PVLs (92.6% vs 83.3%, respectively). Clinical success was achieved in 82.1% of patient cohort without statistical difference among those with isolated aortic or mitral PVL or among those with PVL closure an indication of heart failure or hemolysis. During a mean follow-up of 33.5 months, five patients died, including one periprocedural death. CONCLUSIONS: This multicenter recorded experience confirms that percutaneous PVL closure can be performed with high technical and clinical success rates and limited complications that lead to significant PVL reduction and functional status improvement.

Coronary angioplasty post TAVI: Is the solution outside the box?

Transcatheter aortic valve replacement (TAVR) has become the standard option for high risk patients with bioprosthetic valve degeneration. However, percutaneous coronary interventions after TAVR may be challenging as the manipulation and engagement of the guiding catheters is much more limited and difficult, due to the superimposition of the metallic frame of the TAVR valve upon the bioprosthetic cage. We describe a case of percutaneous coronary intervention in a patient with history of transcatheter aortic valve implantation after bioprosthetic valve degeneration and we describe a new method for accessing coronary arteries in cases of TAVR-in-surgical aortic valve replacement with a high-frame TAVR with a supra-annular leaflet position, by using the route outside the frame. 〈Learning objective: We describe a method for accessing coronary arteries in cases of transcatheter aortic valve implantation (TAVI)-in-surgical aortic valve replacement with a high-frame TAVI with a supraannular leaflet position, by using the route outside the frame.〉.

Transfemoral transcatheter aortic valve replacement in the presence of a mitral prosthesis.

PURPOSE: In the current case series, we present our experience with the self-expanding CoreValve or Evolut R (Medtronic Inc.) in patients with severe symptomatic aortic valve stenosis and concomitant mitral valve prosthesis. METHODS: Twelve patients with previous mitral valve prosthesis underwent transcatheter aortic valve replacement for severe symptomatic aortic valve stenosis and/or aortic valve regurgitation. All patients underwent evaluation with an echocardiogram, computed tomography and coronary angiogram. After the index intervention and before discharge all patients underwent transthoracic echocardiography. All outcomes were defined according to the Valve Academic Research Consortium-2 criteria. RESULTS: Eleven patients underwent transcatheter aortic valve replacement for severe symptomatic aortic valve stenosis and one patient for severe aortic valve regurgitation. There was immediate improvement of patients' hemodynamic status; no cases of procedural death, stroke, myocardial infarction, or urgent cardiac surgery occurred. There was no 30-day mortality and all patients improved, with 91.6% in functional New York Heart Association class I-II. CONCLUSION: The current study demonstrates that in patients with severe aortic valve stenosis or regurgitation and mitral valve prosthesis, the implantation of a self-expanding aortic valve via the transfemoral route is safe and feasible, with maintained long-term results.

Simultaneous implantation of MitraClip devices in a patient with severe mitral and tricuspid valve regurgitation.

We present a case of an 84-year old patient with severe mitral and tricuspid regurgitation with a lot of cormobidities who underwent a simultaneous transfemoral (one approach) mitral and tricuspid valve repair using the MitraClip system.

Catheter Closure Through a Venous Approach of Patent Ductus Arteriosus in Small Pediatric Patients Using Combined Angiographic and Echocardiographic Guidance.

The standard technique of catheter closure of patent ductus arteriosus (PDA) may be associated with arterial complications particularly in small pediatric patients. The aim of this study was to evaluate whether catheter closure of PDA in small children using an exclusive venous approach is a safe and effective alternative to closure with the standard technique. One hundred-twelve patients, aged 2 to 24 months, were randomly assigned in a 1:1 ratio to catheter closure of PDA using the standard technique (group 1) and an exclusive venous approach (group 2), respectively. In group 2, the procedure was guided using hand injections of contrast media through the delivery sheath and 2-dimensional and color Doppler echocardiography. Group 1: the PDA diameter ranged from 2 to 5.5 mm and the device diameter ranged from 4 to 8 mm. The PDA occluders were permanently implanted in all patients. Five losses of the arterial pulses that were restored with intravenous infusion of heparin and recombinant tissue plasminogen activator (rtPA), and 4 groin hematomas were the main complications of the procedure. Group 2: the mean PDA diameter ranged from 2.5 to 6 mm and the device diameter ranged from 3 to 8 mm. The PDA occluders were permanently implanted in all but 2 patients. There were no complications. Complete echocardiographic closure of PDA at 1-month follow-up was observed in all 110 patients. Exclusive transvenous PDA occlusion is an effective and safe technique that prevents the arterial complications of the standard approach in small children.

Is There an Association Between Carotid-Femoral Pulse Wave Velocity and Coronary Heart Disease in Patients with Coronary Artery Disease: A Pilot Study.

Arterial stiffness has been shown to predict cardiovascular morbidity and mortality. Carotid-femoral pulse wave velocity (cfPWV) is regarded the gold standard marker of arterial stiffness. In previous studies, cfPWV was associated with the presence of coronary heart disease (CHD). However, with regard to CHD severity as assessed by the Syntax Score, only brachial-ankle PWV was reported to correlate with Syntax Score; no data exist for cfPWV. In this pilot study, we evaluated the possible associations between cfPWV, CHD and Syntax Score in 62 consecutive pa-tients (49 males; mean age: 64±12years) with chest pain undergoing scheduled coronary angiography. cfPWV was signifi-cantly higher in CHD patients than in non-CHD individuals (10 vs. 8.4 m/s; p = 0.003). No significant association was found between cfPWV and CHD severity as assessed by Syntax Score. A cut-off point of 12.3 m/s was considered as diagnostic for abnormally increased cfPWV (specificity: 97%; sensitivity: 12%; positive likelihood ratio: 3.558). Further research is needed to establish the relationship between cfPWV and Syntax Score.

European expert consensus on rotational atherectomy.

The interest in rotational atherectomy (RA) has increased over the past decade as a consequence of more complex and calcified coronary stenoses being attempted with percutaneous coronary interventions. Yet adoption of RA is hampered by several factors: amongst others, by the lack of a standardised protocol. This European expert consensus document stems from the awareness of the large heterogeneity in the protocols adopted to perform rotational atherectomy. The objective of the present document is to provide some points of consensus among highly experienced operators on the most controversial steps of RA in an attempt to build the basis of a standardised and universally accepted protocol.

Floppy mitral valve/mitral valve prolapse syndrome: Beta-adrenergic receptor polymorphism may contribute to the pathogenesis of symptoms.

BACKGROUND: Certain patients with floppy mitral valve (FMV)/mitral valve prolapse (MVP) may have symptoms that cannot be explained on the severity of mitral valvular regurgitation (MVR) alone; hypersensitivity to adrenergic stimulation has been suggested in this group defined as the FMV/MVP syndrome. METHODS: Ninety-eight patients (75 men, 23 women) with mitral valve surgery for FMV/MVP were studied. Of those 41 (42%) had symptoms consistent with FMV/MVP syndrome [29 men (39%), 12 women (52%)]; median age of symptom onset was 30 years (range 10-63 years) and median duration of symptoms prior to valve surgery was 16 years (range 3-50 years). Ninety-nine individuals (70 men, 29 women) without clinical evidence of any disease were used as controls. Genotyping of ß1 and ß2 adrenergic receptors was performed. RESULTS: ß-Adrenergic receptor genotypes (ß1 and ß2) were similar between control and overall FMV/MVP patients. Subgroup analysis of patients, however, demonstrated that the genotype C/C at position 1165 resulting in 389 Arg/Arg of the ß1 receptor was more frequent in women compared to those without FMV/MVP syndrome and to normal control women (p<0.025). This polymorphism may be related to hypersensitivity to adrenergic stimulation as reported previously in these patients. CONCLUSION: This study shows a large proportion of patients with FMV/MVP, predominantly women, had symptoms consistent with the FMV/MVP syndrome for many years prior to the development of significant MVR, and thus symptoms cannot be attributed to the severity of MVR alone. Further, women with FMV/MVP syndrome, symptoms at least partially may be related to ß1-adrenergic receptor polymorphism, which has been shown previously to be associated with a hyperresponse to adrenergic stimulation.

Catheter closure of atrial septal defects using the Cocoon septal occluder: preliminary results of a European multicenter study.

Despite its simplicity, device closure of atrial septal defects is still associated with rare but potentially lethal complications. In this prospective non-randomized multicenter study we investigated the safety and efficacy of the Cocoon septal occluder (CSO) for closure of atrial septal defects (ASDs) in 92 patients. Median age of the patients was 10.5 years (range 3-61 years) and median weight was 25 kg (range 13-65 kg). The device is an improved new generation double disc design made of Nitinol wire mesh that is coated with platinum using NanoFusion technology. The discs are connected by a waist with diameter ranging from 6mm to 40 mm with 2mm increments. All patients completed a 3-month follow-up. Mean ASD diameter was 21 ± 7 mm (range 10-35 mm), while the mean device diameter was 24 ± 8 mm (range 14-40 mm). The CSO was permanently implanted in all 92 patients. Complete echocardiographic closure of the defect immediately after the procedure or at the one month follow-up, was observed in all 92 patients (100%). No device-related complications were observed during the procedure or at short-term follow-up (range 3-12 months). Our preliminary results indicate that CSO is a promising device for transcatheter closure of ASDs. Further studies are required to document its efficacy, safety and long-term results in a larger patient population.

Transcatheter closure of large atrial septal defects with deficient aortic or posterior rims using the "Greek maneuver". A multicenter study.

OBJECTIVES: We report a modification ("Greek maneuver") of the standard atrial septal defect (ASD) closure technique using the Amplatzer septal occluder (ASO) to facilitate closure of large ASDs with deficient aortic or posterior rims. METHODS: 185 patients (median 10.8, range 3 to 52 years) with large ASDs (mean diameter 26±7 mm, range 20-40 mm) with a deficient aortic (134 patients) or posterior (51 patients) rim underwent catheter closure with the ASO using the "Greek maneuver" under transesophageal guidance. The Greek maneuver is applied when protrusion of the aortic edge of the deployed left disk of the device in to the right atrium is detected by echo. To circumvent this left disk is recaptured and the whole delivery system is pushed inward and leftward into the left atrium where the left disk and the 2/3 of right disk are simultaneously released. This maneuver forces the left disk to become parallel to the septum preventing the protrusion of the device into the right atrium. RESULTS: The ASO was successfully implanted and was associated with complete closure in 175/185 (95%) of the patients. There were no early or late complications related to the procedure during a follow-up period ranging from 6 months to 7 years. CONCLUSIONS: The "Greek maneuver" is a simple quite useful trick that facilitates closure of large ASDs associated with or without deficient aortic or posterior rims.

Cryptogenic stroke after percutaneous closure of an atrial septal defect.

We present the case of a patient who underwent a percutaneous secundum atrial septal defect (ASD II) closure with an undersized septal occluder device. One week and one month later she experienced two transient ischemic attacks. Three-dimensional transesophageal echocardiography (TEE) revealed a residual patent foramen ovale (PFO) with a positive Valsalva bubble test. She underwent a second procedure under the 3D TEE guidance and the PFO was successfully closed percutaneously using a PFO occluder device that was attached to the ASD device. Accurate ASD and PFO morphology assessment and appropriate device selection are the key factors in the success of percutaneous closure. 3D TEE is an innovative diagnostic technique, providing a complete description of the cardiac defect and improving spatial orientation. Real-time 3D TEE is the appropriate guidance for successful and accurate positioning of the device.

The use of the GuideLiner™ catheter as a child-in-mother technique: an initial single-center experience.

Recently, a new interventional guide catheter, the GuideLiner™ catheter, was introduced into the market as a strategy for tackling the problem of stent delivery failure. We implemented this simplified child-in-mother technique in a series of 16 challenging coronary interventions. Balloon and stent delivery was successfully achieved in all cases and the device was both simple to deploy and remove. Apart from two cases of vessel dissection that were managed successfully with stent implantation, no other serious procedural complications were reported.

The use of rotational atherectomy and drug-eluting stents in the treatment of heavily calcified coronary lesions.

INTRODUCTION: The treatment of calcified coronary artery lesions is a challenge for percutaneous angioplasty. Rotational atherectomy is an established technique for the effective modification of these lesions prior to conventional angioplasty and stent implantation. Drug-eluting stents (DES) have shown encouraging results in complex lesions and high-risk patients. METHODS: This retrospective study investigated the immediate and long-term prognosis after treatment with rotational atherectomy (RotA) and DES implantation in 184 patients with calcified coronary artery lesions. RESULTS: During follow up (mean 49 months), 7 patients died (1 from a non-cardiac cause) and the incidence of major adverse cardiac events was 14.85%. Only 4.15% of patients underwent a new angioplasty procedure. CONCLUSIONS: The combination of RotA and DES in calcified coronary artery lesions has a very good angiographic result and a satisfactory clinical outcome.

Rotablation in the drug eluting era: immediate and long-term results from a single center experience.

The aim of this study was to investigate the immediate and long-term outcome of patients who were treated with rotational atherectomy (RA) to facilitate the delivery of drug eluting stents (DES) in heavily calcified lesions. We analyzed 150 consecutive patients who underwent RA and subsequently DES implantation in our institution. The patients had heavily calcified coronary artery lesions requiring plaque modification prior to conventional angioplasty and stent implantation. Rotational atherectomy was performed using the standard Boston Scientific Rotablator system. A 2-burr stepped approach was selected in most of the cases. Following successful modification of the plaque, the angioplasty was performed with a balloon at low pressure to avoid dissection and a DES was implanted. The mean follow up period was 3 years (max. 78 months). Follow-up data included all cause death, stroke, myocardial infarction (MI), recurrent angina, re-hospitalization, target lesion revascularization (TLR), target vessel revascularization (TVR), and long-term duration of dual antiplatelet therapy. The rate of recurrent angina and MI during follow up was low (3.3%) and the overall major adverse cardiac events (MACE) rate was 11.3%. No MACE occurred during hospitalization. There was no relationship between discontinuation of clopidogrel and occurrence of death or MI. The combined approach of RA-DES has a favorable effect when dealing with heavily calcified lesions in both the angiographic and clinical outcomes. No safety concerns are observed up to 6 years.