Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device

D. Mazzitelli, T. Fischlein, JS. Rankin, YH. Choi, C. Stamm, S. Pfeiffer, J. Pirk, C. Detter, J. Kroll, F. Beyersdorf, CD. Griffin, M. Shrestha, C. Nöbauer, PS. Crooke, C. Schreiber, R. Lange,

. 2016 ; 49 (3) : 987-93. [pub] 20150708

Jazyk angličtina Země Německo

Typ dokumentu klinické zkoušky, časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc17001101

OBJECTIVES: This study assessed the safety and efficacy of an internal geometric annuloplasty ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). METHODS: Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic annuloplasty ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. RESULTS: Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the rings were observed. CONCLUSIONS: Geometric ring annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric ring annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc17001101
003      
CZ-PrNML
005      
20230302135622.0
007      
ta
008      
170103s2016 gw f 000 0|eng||
009      
AR
024    7_
$a 10.1093/ejcts/ezv234 $2 doi
024    7_
$a 10.1093/ejcts/ezv234 $2 doi
035    __
$a (PubMed)26156945
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a gw
100    1_
$a Mazzitelli, Domenico $u Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany.
245    10
$a Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device / $c D. Mazzitelli, T. Fischlein, JS. Rankin, YH. Choi, C. Stamm, S. Pfeiffer, J. Pirk, C. Detter, J. Kroll, F. Beyersdorf, CD. Griffin, M. Shrestha, C. Nöbauer, PS. Crooke, C. Schreiber, R. Lange,
520    9_
$a OBJECTIVES: This study assessed the safety and efficacy of an internal geometric annuloplasty ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841). METHODS: Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic annuloplasty ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%. RESULTS: Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the rings were observed. CONCLUSIONS: Geometric ring annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric ring annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a senioři nad 80 let $7 D000369
650    _2
$a aortální chlopeň $x chirurgie $7 D001021
650    _2
$a aortální insuficience $x chirurgie $7 D001022
650    _2
$a anuloplastika srdeční chlopně $x škodlivé účinky $x přístrojové vybavení $x metody $x mortalita $7 D058385
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a srdeční chlopně umělé $x škodlivé účinky $7 D006350
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a prospektivní studie $7 D011446
650    _2
$a reoperace $7 D012086
655    _2
$a klinické zkoušky $7 D016430
655    _2
$a časopisecké články $7 D016428
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Fischlein, Theodor $u Department of Cardiovascular Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.
700    1_
$a Rankin, J Scott $u Cardiothoracic Surgery Associates, Nashville, TN, USA jsrankinmd@cs.com.
700    1_
$a Choi, Yeong-Hoon $u Department of Cardiac and Thoracic Surgery, University of Köln, Cologne, Germany.
700    1_
$a Stamm, Christof $u Department of Cardiac Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany.
700    1_
$a Pfeiffer, Steffen $u Department of Cardiovascular Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.
700    1_
$a Pirk, Jan $u Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
700    1_
$a Detter, Christian $u Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
700    1_
$a Kroll, Johannes $u Department of Cardiovascular Surgery, Albert-Ludwigs University, Freiburg, Germany.
700    1_
$a Beyersdorf, Friedhelm $u Department of Cardiovascular Surgery, Albert-Ludwigs University, Freiburg, Germany.
700    1_
$a Griffin, Charles D $u BioStable Science and Engineering, Inc., Austin, TX, USA.
700    1_
$a Shrestha, Malakh $u Department of Cardiothoracic Surgery, Hannover Medical School, Hannover, Germany.
700    1_
$a Nöbauer, Christian $u Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany.
700    1_
$a Crooke, Philip S $u Department of Mathematics, Vanderbilt University, Nashville, TN, USA.
700    1_
$a Schreiber, Christian $u Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany.
700    1_
$a Lange, Rüdiger, $u Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany. $d 1953- $7 xx0282824
773    0_
$w MED00001607 $t European journal of cardio-thoracic surgery $x 1873-734X $g Roč. 49, č. 3 (2016), s. 987-93
856    41
$u https://pubmed.ncbi.nlm.nih.gov/26156945 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20170103 $b ABA008
991    __
$a 20230302135616 $b ABA008
999    __
$a ok $b bmc $g 1180241 $s 961668
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2016 $b 49 $c 3 $d 987-93 $e 20150708 $i 1873-734X $m European journal of cardio-thoracic surgery $n Eur J Cardiothorac Surg $x MED00001607
LZP    __
$a Pubmed-20170103

Najít záznam

Citační ukazatele

Možnosti archivace