ΠΑΝΕΛΛΗΝΙΑ ΣΕΜΙΝΑΡΙΑ ΟΜΑ ΩΝ ΕΡΓΑΣΙΑΣ Η ελληνική και διεθνής εµπειρία στη διαδερµική σύγκλειση. Μακρόχρονη συµπεριφορά συσκευών σύγκλεισης

Transcription

1 ΠΑΝΕΛΛΗΝΙΑ ΣΕΜΙΝΑΡΙΑ ΟΜΑ ΩΝ ΕΡΓΑΣΙΑΣ Η ελληνική και διεθνής εµπειρία στη διαδερµική σύγκλειση. Μακρόχρονη συµπεριφορά συσκευών σύγκλεισης

2 11% 75% 9%

3 Clinical Background of ASD (CHD: 7% GUCH: 33%) defect size, relative compliance of the ventricles, and relative vascular resistances By the age of 40 years, 90% of untreated patients have symptoms: exertional dyspnea, fatigue, palpitations, sustained arrhythmia (primarily atrial arrhythmias, especially atrial fibrillation), or evidence of heart failure. Most symptomatic adults older than 40 years have mild-to-moderate PAH Murphy NEJM 1990, Hamilton 1987, Campbell Br.H.J 1970, Steele Circulation 1986

4 Beneficial effects of ASD closure in adults Definitive effects RV size LV size Pa pressure RA size Exercise capacity NYHA Class Possible effects Atrial arrhythmias

5 Transcatheter versus Surgical Closure of ASD II in Adults: Impact of Age at Intervention. A Concurrent Matched Comparative Study Martin Rosas et al. Cong. Heart Dis. 2007;2: Objectives. To compare the short- and mid-term outcomes of surgical (SUR) vs. transcatheter closure of secundum atrial septal defect (ASD) using Amplatzer septal occluder (ASO) in adults with a very similar spectrum of the disease; and to identify predictors for the primary end point. Design. Single-center, concurrent comparative study. Surgically treated patients were randomly matched (2:1) by age, sex, date of procedure, ASD size, and hemodynamic profile. Setting. Tertiary referral center. Patients. 162 concurrent patients with ASD submitted to ASO (n = 54) or SUR closure (n = 108) according with their preferences. Main Outcome Measures. Primary end point was a composite index of major events including failure of the procedure, important bleeding, critical arrhythmias, serious infections, embolism, or any major cardiovascular intervention-related complication. Predictors of these major events were investigated. Results. Atrial septal defects were successfully closed in all patients, and there was no mortality. The primary event rate was 13.2% in ASO vs. 25.0% in SUR (P =.001). Multivariate analysis showed that higher rate of events was significantly associated with age >40 years; systemic/pulmonary output ratio <2.1; and systolic pulmonary arterial pressure >50 mm Hg; while in the ASO group the event rate was only associated with the ASD size (>15 cm2/m2; relative risk = 1.75, 95% confidence interval ). There were no differences in the event-free survival curves in adults with ages <40 years. Conclusions. The efficacy for closure ASD was similar in both groups. The higher morbidity observed in SUR group was observed only in the patients submitted to the procedure with age >40 years. The length of hospital stay was shorter in the ASO group. Surgical closure is a safe and effective treatment, especially in young adults. There is certainly nothing wrong with continuing to do surgery in countries where the resources are limited.

6 Long-Term Outcomes After Surgical Versus Transcatheter Closure of Atrial Septal Defects in Adults Kotowycz et al J Am Coll Cardiol Intv. 2013; 6(5): Objectives The purpose of this study was to assess the comparative effectiveness and longterm safety of transcatheter versus surgical closure of secundum atrial septal defects (ASD) in adults. Background Transcatheter ASD closure has largely replaced surgery in most industrialized countries, but long-term data comparing the 2 techniques are limited. Methods We performed a retrospective population-based cohort study of all patients, ages 18 to 75 years, who had surgical or transcatheter ASD closure in Québec, Canada's secondlargest province, using provincial administrative databases. Primary outcomes were long-term (5-year) reintervention and all-cause mortality. Secondary outcomes were short-term (1-year) onset of congestive heart failure, stroke, or transient ischemic attack, and markers of health service use. Results Of the 718 ASD closures performed between 1988 and 2005, 383 were surgical and 335 were transcatheter. The long-term reintervention rate was higher in patients with transcatheter ASD closure (7.9% vs. 0.3% at 5 years, p = ), but the majority of these reinterventions occurred in the first year. Long-term mortality with the transcatheter technique was not inferior to surgical ASD closure (5.3% vs. 6.3% at 5 years, p = 1.00). Secondary outcomes were similar in the 2 groups. Conclusions Transcatheter ASD closure is associated with a higher long-term reintervention rate and long-term mortality that is not inferior to surgery. Overall, these data support the current practice of using transcatheter ASD closure in the majority of eligible patients and support the decision to intervene on ASD with significant shunts before symptoms become evident.

7 Επεµβατική αντιµετώπιση King-Mills ASD Occlusion Device (1976) Rashkind Monodisk Occluder (1987) Lock Clamshell Occluder (1990) Sideris Button Double-Disc Occluder (1990) ASDOS Babic Double Umbrella Occluder (1995) Das Double-Patch Occluder (1996) Cardioseal-Clamshell modif. (1996) Amplatzer Septal Occluder (1996) StarFlex/Cardioseal modif. (1998/2003) Helex Occluder (2000) Occlutech, Solysafe, BioSTAR, BioTEK, Double Bio disc, Gore septal occluder (GSOTM ), Lifetech, Ceraflex,..

8 FDA Commentary Long-term prevention of death and complications is best achieved when the ASD is closed before 40 years of age Overall, regulatory and historical data suggest that acute and chronic results of surgical and percutaneous repairs have balanced benefits and risks. The absolute number and normalized rate of ASD closure has more than doubled since the introduction of transcatheter ASD occluders to the U.S. market in As of 2005, surgery remained the dominant method of ASD repair in the pediatric age range especially under the age of 10, while percutaneous closure was the most common ASD repair procedure overall and is dominant in adults

9 FDA Pivot Major Complication ASO Patients Surgical Control Patients Cardiac Arrhythmia requiring major treatment Device Embolization with surgical removal Device Embolization with percutaneous removal p-value 2/442 (0.5%) 0/154 (0.0%) /442 (0.7%) na --- 1/442 (0.2%) na --- Delivery System Failure 1/442 (0.2%) na --- Pericardial Effusion with tamponade 0/442 (0.0%) 3/154 (1.9%) Pulmonary Edema 0/442 (0.0%) 1/154 (0.6%) 0.26 Repeat Surgery na 2/154 (1.3%) --- Surgical Wound Complication na 2/154 (1.3%) --- Total Major Complications 7/442 (1.6%) 8/154 (5.2%) 0.030

10 Matthias Sigler, Christian Jux. Biocompatibility of septal defect closure devices (32 sheep, 12 human)heart. 2007; 93(4):

11 Percutaneous versus surgical closure of secundum atrial septal defect: Comparison of early results and complications Gianfranco Butera et al. Am Heart J 2006;151: procedures in 1268 consecutive patients with isolated secundum ASD. 533 patients underwent surgical repair (group A). 751 underwent percutaneous ASD closure (group B). There were no postoperative deaths. The overall rate of complications was higher in group A than in group B: 44% (95% CI 39.8%-48.2%) vs 6.9 % (95% CI 5%-8.7%) ( P b.0001). Major complications were also more frequent in group A: 16% (95% CI 13%-19%) vs 3.6% (95% CI 2.2%-5.0%) ( P =.002). Multiple logistic regression analysis showed that surgery was independently strongly related to the occurrence of total complication (odds ratio [OR] 8.13, 95% CI ) and of major complications (OR 4.03, 95% CI ). The occurrence of minor complications was independently related to surgery (OR 7.33, 95% CI ), childhood (OR 1.52, 95% CI ), and presence of systemic hypertension (OR 1.35, 95% CI ). Hospital stay was shorter in group B (3.2 F 0.9 vs 8.0 F 2.8 days, P b.0001). Conclusions Percutaneous ASD closure provides, in experienced hands and in highly specialized centers, excellent results with a lower complication rate and requires a shorter stay in hospital.

12 Closure of atrial septal defect in the adult. Cardiac remodeling is an early event U. Thile n, S. Persson International Journal of Cardiology 108 (2006) Background: Study aimed to describe the extent and the temporal profile of cardiac remodeling after atrial septal defect closure in the adult. Methods: Prospective and longitudinal echocardiographic assessment of right and left heart size before and after (1 day 1 week/1/4/12 months) surgical or catheter-based atrial septal closure in 39 adults (age 54T15 years). Results: Right ventricular and atrial sizes were markedly reduced, left ventricular size increased and left atrial size remained unchanged after closure. Older age and a history of atrial fibrillation reduced the potential to normalize right and left atrial size after closure. The greater part of the changes occurred very early, in the 1st day/1st week. From then on the speed of change gradually diminished and after 4 months no important changes were observed. The mode of closure did not influence the degree or the pace of the remodeling. Conclusion: Cardiac remodeling after atrial septal closure in the adult is a common and early event that seems by and large completed within the first half year after closure. The ventricles seem to have a higher capacity of remodeling than the atria in this setting. The mode of closure does not seem to significantly impact remodeling

13 Closure of Atrial Septal Defect With the Amplatzer Septal Occluder in Adults Transcatheter closure of atrial septal defects (ASDs) was performed mainly in children and adolescents. Information about outcome and complications in adults was limited. From November 1997 to November 2005, percutaneous closure of ASDs using the Amplatzer septal occluder was attempted in 650 consecutive adult patients. Median patient age was 45.8 ± 16.2 years (range 18 to 90), mean systolic artery pressure was 33.3 ± 10.6 mm Hg (range 11 to 85), and mean pulmonary and systemic blood flow (Qp/Qs) ratio was 1.9 ± 0.7 (range 0.8 to 6.6). Mean stretched diameter of the ASD was 21.2 ± 5.1 mm (range 3.1 to 43). Seventy-eight patients (12%) had multiple defects. Of 572 patients with a single ASD, device implantation was successful in 563 patients (98%). During follow-up, complete closure could be achieved in 96% of patients with a single ASD and 71% of patients with multiple defects. Mean systolic artery pressure decreased to 28.3 ± 10.1 mm Hg and mean Qp/Qs ratio decreased to 1 ± 0.3. The 3 complications that occurred during the procedure were device embolization (2 patients; 0.3%) and transient ST depression (1 patient; 0.2%). The most common complication immediately after the procedure and during follow-up was new-onset atrial fibrillation (28 patients; 4.3%). Electrical cardioversion was successfully in most. Complications requiring emergency or elective surgery occurred in 6 patients (0.9%; hemopericardium, 2 patients, 0.3%; device embolization, 3 patients, 0.5%, and pericardial tamponade, 1 patient, 0.2%). In conclusion, closure of ASDs using the Amplatzer septal occluder in adults was efficient and safe, with excellent long-term success rates. Serious complications were rare. N. Majunke et al. American Journal of Cardiology, Volume 103, Issue 4, Pages , 15 February 2009

14 Types of Adverse Events Maude Database ( Implants) Device Embolization 0,27 % 0 Cardiac Perforation 0,12 % 10 Thromboembolic 0,03 % (A-Fib) 0 Complications Residual defect 0,02% 0 Arrhythmias 5 % AV-Block 0,3% Nickel Allergy 0,01 % 0 Device Infection 0.01 % Erosions 0,17% 13

15 Short and Long Term Complications of Device closure of ASD and PFO Meta Analysis of pts from 203 studies Catheter Cardiovasc Interv Dec 1;82(7): from 203 studies 111 (ASD) 61 (PFO) 31 (ASD+PFO) 3 deaths (2 PFO/ 1 ASD) Peri-procedural complications (embolization, tamponade)1,4% (0-9%) Major 216/ ,8% (>PFO) TIA (22x) 0,1 % Thrombosis (7x) 0,0% Retroperitoneal hematoma Pulmonary edema Erosions (5x) send to Op Pacemaker (12x) (12x) (5x) (1x) Minor 271/ % Follow up ( m.) 97 deaths 21 related to the device (2 emb. 2 tamp.) TIAS 1,3% Thrombosis 1% Late erosion 0,04% Heart block 0,2%

16 Reinhardt et al. Interact Cardiovasc Thorac Surg. 2012; 15(5): Moore et al. Safety of Transcatheter ASD Closure JACC (2013) 6:433-42

17 Incidence Rates of Device Erosion Based on Data from December 1998 to March 2012 (Data Presented at PICS 2012) Number of erosions Sales Implantation cards Incidence Worldwide %-0.17% USA %-0.11% FDA pivot trial %

18 ASD II, επεµβατική θεραπεία στην Ελλάδα (κέντρα >12 devices έτος) 120 (!! '!! &!! %!! $!! #!! "!! ! ) ** +,- +,. /, 0, 1,23 4, 5, OCC A.S A.L!. I. ". # $. D.

19 Complications of Device closure of ASD and PFO OCC (>800 procedures (158 PFO) Death 0 Peri-procedural complications (embolization) 2 Major TIA Thrombosis» Retroperitoneal hematoma 0» Pulmonary edema 1» Erosions send to Op 0» Pacemaker 0 (1x) (2x) Minor 6x Follow up deaths 1 TIAS 1 (+?) Thrombosis 1 (1+) Late erosion 0 Heart block 1

20 Closure of an ASD ACC/AHA 2010 (2008) CLASS I 1. Closure of an ASD either percutaneously or surgically is indicated for right atrial and RV enlargement with or without symptoms. (Level of Evidence: B) 2. A sinus venosus, coronary sinus, or primum ASD should be repaired surgically rather than by percutaneous closure. (Level of Evidence: B) 3. Surgeons with training and expertise in CHD should perform operations for various ASD closures. (Level of Evidence: C) CLASS IIa 1. Surgical closure of secundum ASD is reasonable when concomitant surgical repair/replacement of a tricuspid valve is considered or when the anatomy of the defect precludes the use of a percutaneous device. (Level of Evidence: C) 2. Closure of an ASD, either percutaneously or surgically, is reasonable in the presence of: a. Paradoxical embolism. (Level of Evidence: C) b. Documented orthodeoxia-platypnea. (Level of Evidence: B) CLASS IIb 1. Closure of an ASD, either percutaneously or surgically, may be considered in the presence of net left-to-right shunting, pulmonary artery pressure less 2/3 systemic levels, PVR less than 2/3 systemic vascular resistance, or when responsive to either pulmonary vasodilator therapy or test occlusion of the defect (patients should be treated in conjunction with providers who have expertise in the management of pulmonary hypertensive syndromes). (Level of Evidence: C) 2. Concomitant Maze procedure may be considered for intermittent or chronic atrial tachyarrhythmias in adults with ASDs. (Level of Evidence: C) CLASS III 1. Patients with severe irreversible PAH and no evidence of a left-to-right shunt should no undergo ASD closure (Level of Evidence: B)

21

22 New Devices

23 ΥΛΙΚΟ ΚΑΙ ΜΕΘΟΔΟΙ 199 ασθενείς >16 ετών (63% γυναίκες), µέση ηλικία 42,3 ±17,8 έτη. Σύγκλειση ASD Mάϊο 2000 έως Δεκέµβριο ,6 έτη (1 έως 10,5 έτη) µετά τη σύγκλειση. Ερωτηµατολόγια: Ποιότητας ζωής (SF-36 QoL) Beck Depression Inventory (BDI) Zung Self-rating Depression Scale (Zung SDS)

24 ΑΠΟΤΕΛΕΣΜΑΤΑ 10 (11.2%) ασθενείς ήταν καταθλιπτικοί βάσει BDI και 15 (16.8%) βάσει Zung SDS Συνολικά 9 ασθενείς (10.1 %), µέσης ηλικίας 47,7 έτη, ήταν καταθλιπτικοί µε βάση και τις δυο κλίµακες κατάθλιψης ( πάνω απο τα cut-off όρια) εν βρέθηκε συσχέτιση µε την ηλικία σύγκλεισης (p=0.93) και το χρόνο που µεσολάβησε µεταξύ της σύγκλεισης και της µελέτης (p=0.69).

25