Very long-term outcomes of transcatheter secundum atrial septal defect closure using intracardiac echocardiography without balloon sizing.

AIM: To assess the long-term outcomes of device-based closure of atrial septal defects (ASDs) with no sizing balloon. MATERIAL AND METHODS: Two hundred and eighty-one consecutive patients (mean age 34±13 years, 178 women) underwent intracardiac echocardiography (ICE)-aided transcatheter closure of secundum ASDs over a 15-year period (September 2002 to March 2017). Sizing of the ASDs was calculated under ICE guidance (UltraICE, EP Technologies, Boston Scientific Corporation, San Jose, CA, USA) using the concept of "supportive rim" for ASDs without the aid of a sizing balloon. Follow-up was conducted by transoesophageal and transthoracic echocardiography. RESULTS: The procedure was carried out successfully in all patients with 0% related mortality and 5.7% procedural complications. The Amplatzer ASD Occluder was implanted in 251 patients (89.3%, mean size 26.4±10.2 mm) whereas the Gore Cardioform was used in 30 patients (10.6%). Over 10.3±3 years of follow-up (range 1-15) 100% of patients were alive. The complete occlusion rate was 97.8%. No aortic or atrial free wall erosions, device thrombosis, or device frame fractures were detected during the follow-up period. CONCLUSION: The present study suggested that ICE-guided closure of ASDs with current devices without sizing balloons is safe and effective with very low procedural and late complications even in the very long-term follow-up.

Patent foramen ovale-mania: an unusual case of misdiagnosis.

Patent foramen ovale (PFO) is rapidly becoming in Europe, more than in the USA, a matter of over-diagnosis and over-treatment. A migrainous 34-year-old female with episodic hypostenia and even paralysis of the left arm was referred to a peripheral hospital for a complete neurological work-up. Being the Doppler ultrasound of carotid and vertebral arteries negative and angio-magnetic resonance imaging (MRI) positive for multiple white-matter lesions. A transthoracic echocardiography revealed a possible shunt through a patent foramen ovale with a right-to-left shunt and a mild buldging of interatrial septum, but the patient did not tolerate a further attempt of transesophageal echocardiography to confirm the diagnosis. Coagulation screening essay demonstrated a moderate hyperhomocisteinemia. In the hypothesis of embolic PFO mediated by a moderate prothrombotic state caused by hyperhomocisteinemia, the patient was referred to our attention for an attempt of PFO closure but on intracardiac echocardiography normal fossa ovalis without any shunt was revealed. One year later, during the follow-up, the patient became severely symptomatic for left arm hypostenia and parhestesia, both at rest and during efforts. Thus, the patient was submitted to a thoracic and upper limbs angio-MRI in order to exclude disease of the main arteries causing functional impotence. The MRI demonstrated thoracic outlet syndrome of both arms, more severe in the left arm with functional occlusion of the subclavian vein with abduction of the arm and possible cloth image at the subclavian vein next to the joint. The patient was referred to the thoracic surgeon for surgical repair.

In high risk hypertensive subjects with incidental and unilateral renal artery stenosis percutaneous revascularization with stent improves blood pressure control but not glomerular filtration rate.

AIM: In high-risk hypertensive subjects (HTs) with incidental unilateral renal artery stenosis (RAS), the effectiveness of percutaneous revascularization with stent (PR-STENT) on blood pressure (BP) and glomerular filtration rate (GFR) is not established. METHODS: Eighteen HTs aged 65.7 ± 9.2 years with angiographically diagnosed unilateral RAS (≥ 60%) were randomized to receive PR-STENT (N=9) or to NO-STENT (N=9). BP (mercury sphygmomanometer) and GFR (99mTc-DTPA clearances during renal scintigraphy) were evaluated yearly for three years. Echo-Doppler of renal arteries was performed to verify the anatomic patency and flow velocities of the reperfused artery. Analysis of variance compared BP and GFR values changes from baseline to the follow-up; differences for continuous variables were evaluated between groups with the Tukey's post hoc test after adjustment for age, change of BP between baseline and at the follow-up, GFR and body mass index (BMI). RESULTS: Baseline systolic BP and GFR values were not different between groups. The significantly greater GFR increase observed in PR-STENT than in NO-STENT at univariate analysis at the end of follow-up (62.5 ± 19.2 vs. 42.24 ± 17.6, P<0.02) disappeared after adjustment for confounding factors. However, systolic BP remained significantly lower in PR-STENT than in NO-STENT (140.1 ± 4.6 vs. 170.0 ± 8.3, P<0.0001) also after adjustment for age, GFR and BMI. CONCLUSION: PR-STENT reduces systolic BP without improving GFR. Due to the strong association between high BP and renal damage, this study raises the question on whether PR-STENT should be performed in all HTs with unilateral and incidental RAS.

The risk of thrombosis after acute-COVID-19 infection.

Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has been associated with coagulation dysfunction which predisposes patients to an increased risk of both venous and arterial thromboembolism, increasing the short-term morbidity and mortality. Current data evidenced that the rate of post-discharge thrombotic events in COVID-19 patients is lower compared to that observed during hospitalization. Rather than 'true thrombotic events', these complications seem more probably 'immunothrombosis' consequent to the recent infection. Unfortunately, the absence of data from randomized controlled trials, large prospective cohorts and ambulatory COVID-19 patients, left unresolved the question regarding the need of post-discharge thromboprophylaxis due to the absence of strong-level recommendations.

Dyslipidaemia and mortality in COVID-19 patients: a meta-analysis.

BACKGROUND: The prevalence and prognostic implications of pre-existing dyslipidaemia in patients infected by the SARS-CoV-2 remain unclear. AIM: To assess the prevalence and mortality risk in COVID-19 patients with pre-existing dyslipidaemia. DESIGN: Systematic review and meta-analysis. METHODS: Preferred reporting items for systematic reviews and meta-analyses guidelines were followed in abstracting data and assessing validity. We searched MEDLINE and Scopus to locate all the articles published up to 31 January 2021, reporting data on dyslipidaemia among COVID-19 survivors and non-survivors. The pooled prevalence of dyslipidaemia was calculated using a random-effects model and presenting the related 95% confidence interval (CI), while the mortality risk was estimated using the Mantel-Haenszel random-effect models with odds ratio (OR) and related 95% CI. Statistical heterogeneity was measured using the Higgins I2 statistic. RESULTS: Of about 18 studies, enrolling 74 132 COVID-19 patients (mean age 70.6 years), met the inclusion criteria and were included in the final analysis. The pooled prevalence of dyslipidaemia was 17.5% of cases (95% CI: 12.3-24.3%, P < 0.0001), with high heterogeneity (I2 = 98.7%). Pre-existing dyslipidaemia was significantly associated with higher risk of short-term death (OR: 1.69, 95% CI: 1.19-2.41, P = 0.003), with high heterogeneity (I2 = 88.7%). Due to publication bias, according to the Trim-and-Fill method, the corrected random-effect ORs resulted 1.61, 95% CI 1.13-2.28, P < 0.0001 (one studies trimmed). CONCLUSION: Dyslipidaemia represents a major comorbidity in about 18% of COVID-19 patients but it is associated with a 60% increase of short-term mortality risk.

Safety and long-term results of patent foramen ovale transcatheter closure in patients with thrombophilia.

AIM: Trials on transcatheter closure of patent foramen ovale (PFO) in different settings attempted to exclude patients with thrombophilia for the risk of device thrombosis. Authors sought to retrospectively evaluate safety and results of transcatheter PFO closure in patients with confirmed coagulation abnormalities. METHODS: Between December 2006 and December 2008, 30 out of 98 consecutive patients (mean age 40+/-10.9 years, 23 females) referred to Rovigo General Hospital for transcatheter closure had coagulation abnormalities including mutations of factor V Leiden, factors X, VIII, protein C, S, MHFTR factors, and antiphospholipid and anticardiolipin antibodies, hyperhomocisteinimia. All patients underwent preoperative transesophageal echo and brain magnetic resonance imaging, and intra-cardiac echo-guided transcatheter PFO closure. RESULTS: Success rate was 100%; there was no difference in occlusion and complications rates between patients with and without thrombophilia: in particular no device thrombosis or recurrent cerebral ischemia or stroke were observed during the follow-up. Patients with thrombophilia had a higher incidence of atrial septal aneurysm, migraine with aura and deep venous thrombosis in the previous medical history compared to patients without. CONCLUSIONS: Despite its small sample, this study suggests that patients with coagulation abnormalities should not be excluded from the trial; they have potentially a higher risk of stroke through a PFO compared to other patients, and transcatheter closure is as safe and effective as in general population with almost no additional therapy rather than aspirin.

Intracardiac echocardiography-guided atrial septal defect transcatheter closure of a very old surgical residual shunt.

Although some studies have suggested excellent long-term outcome, arrhythmias, pulmonary hypertension, and paradoxical cerebral embolism are mentioned as results of residual shunts in the long-term follow-up after surgical atrial septal defect (ASD) closure at a young age. In cases of previous patch closure, transcatheter repair of residual shunts can be problematic due both to clinical decision-making in the presence of elevated pulmonary pressure and to a very old patch. A 70-year-old woman operated for an ASD with synthetic patch closure when she was 35 years old was referred to our center because of recurrent paroxysmal atrial fibrillation, initially decompensated right heart failure with rest and exercise-induced dyspnea as results of a residual shunt and moderate pulmonary hypertension. Complete right heart catheterization confirmed a mean pulmonary pressure of about 55 mm Hg and a Qp:Qs ratio of 1.78. A mechanical intracardiac echocardiography study with a 9F 9 MHz UltraICE catheter (Boston Scientific Corp.) showed a highly echogenous interatrial patch with a very stiff appearance and a very high residual defect of 8.7 and 11.2 mm on the aortic valve plane and on the four-chamber views, respectively. An occlusion test with a compliant AGA medical balloon demonstrated a decrease in mean pulmonary pressure to 36 mm Hg. A 10 mm Amplatzer's ASD occluder was implanted after a first unsuccessful attempt due to patch stiffness. Three-month echocardiography follow-up demonstrated almost normal pulmonary pressure and only slight dilation of the right chambers. At six-month follow-up, the patient no longer experienced dyspnea. This case demonstrates that transcatheter closure of a residual shunt following surgical ASD repair can be successfully accomplished also in elderly patients with a very old patch and decompensated right heart failure: the balloon occlusion test and intracardiac echocardiography appear to be effective in the operative decision-making process.

Early post-procedural migraine attack predicts migraine resolution after patent foramen ovale transcatheter closure.

AIM: In patients with patent foramen ovale-related migraine, the procedure of transcatheter closure itself is likely to cause a migraine attack. Our study is aimed to evaluate the incidence of migraine attacks immediately after closure procedure and their clinical and potential prognostic significance. METHODS: We reviewed our database from January 2005 to April 2007 searching for patients with severe disabling migraine despite anti-headache therapy who were submitted to transcatheter closure of patent foramen ovale (PFO). Medical records of these patients were carefully reviewed in order to record migraine episodes immediately (0 to 6 h) after closure procedure. RESULTS: Twenty-one patients with previous stroke and migraine underwent PFO closure: the procedure was successful in all of the patients with no perioperative and in-hospital complications. Ten patients (47.6%) experienced a migraine attack of mean duration 3.5+/-2.4 h immediately after the closure procedure. Those patients had the same procedure time compared with other patients, but had larger PFO: patients with migraine attack immediately after closure had higher rate of complete abolition of migraine in the follow-up. CONCLUSION: Although more larger studies are needed to evaluate the exact relationships between migraine and PFO, in patients with a tight correlation between migraine and PFO, a prolonged opening of the PFO, as during closure procedure, may cause a migraine attack immediately after the closure. This fact can be considered a positive prognostic factor for migraine abolishment in the follow-up.

Patent foramen ovale management: who should do what?

Although definitive evidence of effectiveness of percutaneous patent foramen ovale (PFO) closure is still debated and closure seems to be recommendable only for secondary prevention of stroke, many different specialists may be involved in diagnosis and treatment of the different PFO-related syndromes. When many different professionals are involved in the same patient management, confusion about who does make the diagnosis and who does take decision about medical or interventional therapy would be frequent and correct judgment and actions would be delayed. The authors propose a model of multidisciplinary protocol to manage PFO-related syndrome, in which each specialists has a specific role during the decision-making process that is driven by the cardiologist.

Endovascular treatment of femoro-popliteal obstructive disease.

The systemic nature of vascular atherosclerosis is beginning to involve not only the angiologists and the vascular surgeons, but also the clinical and the invasive cardiologists. Femoral occlusive disease is one of the most challenging field due to the particular anatomical morphology of the femoral arterial wall that is prone to obstructive disease and high restenosis rate after percutaneous revascularization. Acute and chronic arterial diseases are the main clinical scenario involving femoral vessels. Percutaneous techniques include endoluminal recanalization, subintimal recanalization, stent implantation, mechanical and rheolytic thrombectomy, laser angioplasty, and cryoplasty. In this review the authors propose an overview and an update of the most recent advances in techniques and results in the field of endovascular treatment of femoral artery occlusive disease.

Predictors of renal artery stenosis in patients with normal renal function undergoing coronary angiography.

AIM: A number of patients with normal renal function undergoing coronary angiography have shown a renal artery stenosis (RAS). Detection of unknown RAS may influence therapeutic strategy in patients with coronary artery disease (CAD) candidate to coronary revascularization. Prevalence of RAS in patients with normal renal function has not been yet fully investigated. We retrospectively evaluated the prevalence of RAS in patients with normal renal function undergoing coronary angiography and candidate to coronary revascularization. METHODS: Medical records of consecutive patients underwent coronary angiography at a single public institutions over a twelve-month period were evaluated. Patients with normal renal function undergoing coincident diagnostic renal angiography to evaluate renal vessels on the basis of clinical criteria and at least one-vessel CAD were analyzed. Moderate to severe arterial stenosis (>50% stenosis), vessel occlusion were noted as significant angiographic findings. RESULTS: Angiographically significant RAS were reported in 35 (17%) of 205 consecutive patients (mean age 67.1+/-12.8 years, mean serum creatinine 0.8+/-0.5 mg/dL, mean glomerular filtration rate 112+/-13 mL/min). Twenty patients (9.8% of total) underwent renal angioplasty and stenting before successful coronary revascularization. Multivariate logistic regression analyses revealed three-vessel CAD (odds ratio[OR] 8.71; 95% confidence interval [CI] 2.24-40.8; P=0.002), hypertension (OR 2.34 CI 95% 0.96-6.9; P=0.048), and hypercholesterolemia (OR 2.851; CI 95% 1.03 to 7.9; P=0.044) as independent predictors of RAS. CONCLUSIONS: The association of significant RAS with CAD is relatively high in patients with normal renal function. Renal semi-selective or selective angiography may contribute to detect unknown significant RAS in patients undergoing coronary angiography: our small series suggests that this strategy may be useful also in patients with normal renal function in presence of three- or four-vessel CAD and multiple risk factors.

Estimating mean pulmonary wedge pressure in patients with chronic atrial fibrillation from transthoracic Doppler indexes of mitral and pulmonary venous flow velocity.

OBJECTIVES: We sought to obtain a noninvasive estimation of mean pulmonary wedge pressure (MPWP) in patients with chronic atrial fibrillation (AF). BACKGROUND: It has previously been demonstrated that MPWP can be reliably estimated from Doppler indexes of mitral and pulmonary venous flow (PVF) in patients with sinus rhythm. Doppler estimation of MPWP has not been validated in patients with AF. METHODS: MPWP was correlated with variables of mitral and pulmonary venous flow velocity as assessed by Doppler transthoracic echocardiography in 35 consecutive patients. The derived algorithm was prospectively tested in 23 additional patients. RESULTS: In all patients the mitral flow pattern showed only a diastolic forward component. A significant but relatively weak correlation (r = -0.50) was observed between MPWP and mitral deceleration time. In 12 (34%) of 35 patients, the pulmonary vein flow tracing demonstrated only a diastolic forward component; a diastolic and late systolic forward flow was noted in the remaining 23 patients (66%). A strong negative correlation was observed between MPWP and the normalized duration of the diastolic flow (r = -0.80) and its initial deceleration slope time (r = -0.91). Deceleration time > 220 ms predicted MPWP < or = 12 mm Hg with 100% sensitivity and 100% specificity. When estimating MPWP by using the equation MPWP = -94.261 PVF deceleration time -9.831 Interval QRS to onset of diastolic PVF -16.337 Duration of PVF + 44.261, the measured and predicted MPWP closely agreed with a mean difference of -0.85 mm Hg. The 95% confidence limits were 4.8 and -6.1 mm Hg. CONCLUSIONS: In patients with chronic AF, MPWP can be estimated from transthoracic Doppler study of PVF velocity signals.

Demand dynamic cardiomyoplasty: mechanograms prove incomplete transformation of the rested latissimus dorsi.

BACKGROUND: In dynamic cardiomyoplasty, standard stimulation produces high fatigue resistance but also undesirable dynamic characteristics of the latissimus dorsi (LD). Based on results of intermittent stimulation in animals we introduced demand stimulation, a lighter regimen of LD activity-rest stimulation, and the mechanogram, a noninvasive method to determine the contractile characteristics of LD wrap. METHODS: Surgery and standard stimulation was according to the technique of Carpentier and Chachques, demand stimulation and LD wrap mechanogram were as we previously described. The LD contraction is synchronized to heart systole by mechanogram and echocardiography, and extent of transformation by tetanic fusion frequency analysis. A total of 22 patients were studied to date. Data for the 8 subjects who attained 6-month follow-up are reported. Four of them were lightly stimulated from the conditioning period, whereas 4 others were converted to light and then demand stimulation after years of standard stimulation. Patients were followed up with respect to survival, functional class, hospital admission rate, medication used, cardiopulmonary exercise testing, and LD wrap mechanography. RESULTS: Latissimus dorsi wrap slowness reverses by the activity-rest regimen, even after years of standard stimulation (Tetanic fusion frequency of 11 +/- 2 Hz after standard stimulation vs 30 +/- 3 Hz after demand regimen, p < 0.0001). After demand dynamic cardiomyoplasty there are no deaths. Quality of life is substantially improved with significant reduction of heart failure symptoms (New York Heart Association class: preoperative 3.0 +/- 0.0, post-demand dynamic cardiomyoplasty 1.5 +/- 0.2, p < 0.0001). In the subgroup of patients lightly stimulated from LD conditioning, exercise capacity tends to increase over preoperative values more than 2 years after operation (VO2 max: preoperative 12.3 +/- 0.7 vs 16.6 +/- 1.7 post-demand dynamic cardiomyoplasty, p = 0.05). CONCLUSIONS: Demand stimulation and mechanography of the LD wrap are safe procedures that could offer long-term benefits of dynamic cardiomyoplasty to patients with pharmacologically intractable heart failure.

Use of Amplatzer septal occluder in a case of residual atrial septal defect causing bidirectional shunting after percutaneous Inoue mitral balloon valvuloplasty.

We describe a 70-year-old woman who underwent successful percutaneous Inoue antegrade-technique mitral valvuloplasty. Three months later, the patient developed right-sided heart failure. Color Doppler echocardiography and cardiac catheterization demonstrated an atrial septal defect with bidirectional shunting and no restenosis of the mitral valve (iatrogenic Lutembacher's syndrome). Percutaneous treatment was successfully accomplished using a 13 mm Amplatzer Septal Occluder (AGA Medical Corporation, Golden Valley, Minnesota). The causes of right-to-left shunting and the effects of body position on gas exchange in such patients are also discussed.

New hopes for dynamic cardiomyoplasty from use of Doppler flow wire in evaluation of demand stimulation.

BACKGROUND: There are no data regarding real cardiac assistance in demand dynamic cardiomyoplasty (DDCMP). A test of the use of Doppler flow wire is presented to demonstrate cardiac assistance in DDCMP. METHODS: Comparative study in hospitalized care. A peripheral Flex Doppler flow wire of 0.018 inch was advanced through a 4F introducer femoral arterial in seven DDCMP patients (age=57.1+/-6.2 years; NYHA= 1.4+/-0.5). A short period of 10 sec with stimulator off and a following period of 15 sec with clinical stimulation were recorded. We measured the maximum peak aortic flow velocity (MPAV) in all beats. Latissimus dorsi (LD) mechanogram was simultaneously recorded. RESULTS: Statistical analysis showed an increase not only in MPAV in assisted period versus rest, but also in assisted beats versus unassisted (8.42+/-6.98% and 7.55+/-3.07%). CONCLUSIONS: Intravascular Doppler proved real systolic assistance in DDCMP; in DDCMP systolic assistance is correlated to the LD wrap speed of contraction, suggesting that demand stimulation could be the most effective protocol in dynamic cardiomyoplasty.

Demand dynamic bio-girdling in heart failure: improved efficacy of dynamic cardiomyoplasty by LD contraction during aortic out-flow.

PURPOSE: The value of dynamic cardiomyoplasty has been brought into question by the disappointing results produced by slow contraction-relaxation cycle and possibly degeneration of the latissimus dorsi muscle (LD) secondary to temporary tenotomy and chronic daily electrical stimulation. Objective of our study is to determine whether daily periods of rest introduced by demand stimulation in the continuous contraction protocol produce systolic assistance and improve clinical results. METHODS: Twelve dynamic cardiomyoplasty patients (mean age 58.2 +/- 5.8 years, M/F=11/1, sinus rhythm/atrial fibrillation=11/1) with dilated myocardiopathy were enrolled in an unrandomized trial of Demand Dynamic Heart Bio-Girdling in a public regional teaching hospital. Periods of LD inactivity, each lasting several hours, were introduced daily on a heart rate-based demand regime. To avoid full transformation of LD, fewer impulses per day were delivered, daily providing the LD with long periods of rest (Demand light stimulation). The contractile properties were measured by transcutaneous non-invasive LD tensiomyogram interrogation (LD tensiomyogram). Bio-Girdle activation was synchronized to heart beat by combining tensiomyogram and echocardiography. Clinical, echocardiographic and hemodynamic records, as well as aortic flow measurements by Doppler aortic flow wire were taken during the follow-up. MAIN FINDINGS: Mean duration of the demand stimulation follow-up was 40.2+13.8 months. At five years, "Demand stimulation" shows: 1) no operative death; 2) 83% actuarial survival; 3) highly significant 47.4% decrease of the NYHA class (from 3.17 +/- 0.38 to 1.67 +/- 0.77, p=0.0001); 4) 41.6% improvement of LVEF (from 22.6 +/- 4.38 to 32.0 +/- 7.0, p=0.001); 5) 7.5 +/- 3.0% increase in aortic flow velocity peak in assisted vs. unassisted beats, and 6) preservation of LD from slowness (TFF value 33 +/- 7.86 at follow-up versus 15.8 +/- 11.1 Hz just before switching from continuous to demand stimulation, p=0.0001) and muscle degenerative atrophy. CONCLUSIONS: In dynamic cardiomyoplasty the demand light stimulation maintains LD contraction properties over time, produces effective systolic assistance, and improves clinical results. Demand dynamic bio-girdling is a safe and effective treatment for end-stage heart failure in selected patients.

Diagnostic coronary arteriography in the interventional era: a combination of technical advancements, new mental attitude, and improved skill.

Over the past 20 years, coronary angiography has taken many important steps forward in enhancing its ability to detect coronary artery disease. The major improvements in techniques and materials for percutaneous transluminal coronary angioplasty and stenting have led to the progressively widespread use of percutaneous revascularization in an increasing number of patients, including complex and multi-vessel disease. It is commonly believed that this improved interventional prospect has changed the way diagnostic coronary artery angiography is performed among the invasive and interventional cardiology community. The complete development of the coronary tree with more angulated views, the use of intracoronary nitrates in cases of moderate stenosis or spastic coronary trees and adequate balloon and stent sizing, improved magnification of acquisition, when a precise assessment of bifurcation or ostial stenosis is required or when a stented coronary segment is evaluated, and finally an interventional mental attitude, are an integral part of the invasive cardiologist's tools and skills matching the major technical improvements in equipment and materials.