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Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: Results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial

Objectives PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). Background Percutaneous MR reduction has been performed thr... Full description

Journal Title: The American heart journal 2013, Vol.165 (5), p.761-769
Main Author: MacHaalany, Jimmy, MD
Other Authors: Bilodeau, Luc, MD , Hoffmann, Rainer, MD , Sack, Stefan, MD , Sievert, Horst, MD , Kautzner, Josef, MD , Hehrlein, Christoph, MD , Serruys, Patrick, MD, PhD , Sénéchal, Mario, MD , Douglas, Pamela, MD , Bertrand, Olivier F., MD, PhD
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: United States: Mosby, Inc
ID: ISSN: 0002-8703
Link: https://www.ncbi.nlm.nih.gov/pubmed/23622913
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title: Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: Results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial
format: Article
creator:
  • MacHaalany, Jimmy, MD
  • Bilodeau, Luc, MD
  • Hoffmann, Rainer, MD
  • Sack, Stefan, MD
  • Sievert, Horst, MD
  • Kautzner, Josef, MD
  • Hehrlein, Christoph, MD
  • Serruys, Patrick, MD, PhD
  • Sénéchal, Mario, MD
  • Douglas, Pamela, MD
  • Bertrand, Olivier F., MD, PhD
subjects:
  • Abridged Index Medicus
  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization
  • Cardiac patients
  • Cardiology
  • Cardiovascular
  • Care and treatment
  • Echocardiography
  • Female
  • Follow-Up Studies
  • Heart attacks
  • Heart failure
  • Heart Failure - complications
  • Heart Failure - diagnostic imaging
  • Heart Failure - physiopathology
  • Heart Valve Prosthesis Implantation - instrumentation
  • Humans
  • Hypertension
  • Laboratories
  • Male
  • Middle Aged
  • Mitral Valve - diagnostic imaging
  • Mitral Valve - physiopathology
  • Mitral Valve - surgery
  • Mitral Valve Annuloplasty - instrumentation
  • Mitral valve insufficiency
  • Mitral Valve Insufficiency - complications
  • Mitral Valve Insufficiency - physiopathology
  • Mitral Valve Insufficiency - surgery
  • Morbidity
  • Mortality
  • Patients
  • Prospective Studies
  • Treatment Outcome
  • Ventricular Remodeling
ispartof: The American heart journal, 2013, Vol.165 (5), p.761-769
description: Objectives PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). Background Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. Methods Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. Results A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm2 or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m ( P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm2 ( P = .001) and less prior history of myocardial infarction ( P = .02), coronary artery bypass surgery ( P = .03), and ischemic MR ( P = .04). Conclusions Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0002-8703
fulltext: fulltext
issn:
  • 0002-8703
  • 1097-6744
url: Link


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titleTreatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: Results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial
sourceAlma/SFX Local Collection
creatorMacHaalany, Jimmy, MD ; Bilodeau, Luc, MD ; Hoffmann, Rainer, MD ; Sack, Stefan, MD ; Sievert, Horst, MD ; Kautzner, Josef, MD ; Hehrlein, Christoph, MD ; Serruys, Patrick, MD, PhD ; Sénéchal, Mario, MD ; Douglas, Pamela, MD ; Bertrand, Olivier F., MD, PhD
creatorcontribMacHaalany, Jimmy, MD ; Bilodeau, Luc, MD ; Hoffmann, Rainer, MD ; Sack, Stefan, MD ; Sievert, Horst, MD ; Kautzner, Josef, MD ; Hehrlein, Christoph, MD ; Serruys, Patrick, MD, PhD ; Sénéchal, Mario, MD ; Douglas, Pamela, MD ; Bertrand, Olivier F., MD, PhD
descriptionObjectives PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). Background Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. Methods Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. Results A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm2 or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m ( P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm2 ( P = .001) and less prior history of myocardial infarction ( P = .02), coronary artery bypass surgery ( P = .03), and ischemic MR ( P = .04). Conclusions Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.
identifier
0ISSN: 0002-8703
1EISSN: 1097-6744
2DOI: 10.1016/j.ahj.2013.01.010
3PMID: 23622913
4CODEN: AHJOA2
languageeng
publisherUnited States: Mosby, Inc
subjectAbridged Index Medicus ; Aged ; Aged, 80 and over ; Cardiac Catheterization ; Cardiac patients ; Cardiology ; Cardiovascular ; Care and treatment ; Echocardiography ; Female ; Follow-Up Studies ; Heart attacks ; Heart failure ; Heart Failure - complications ; Heart Failure - diagnostic imaging ; Heart Failure - physiopathology ; Heart Valve Prosthesis Implantation - instrumentation ; Humans ; Hypertension ; Laboratories ; Male ; Middle Aged ; Mitral Valve - diagnostic imaging ; Mitral Valve - physiopathology ; Mitral Valve - surgery ; Mitral Valve Annuloplasty - instrumentation ; Mitral valve insufficiency ; Mitral Valve Insufficiency - complications ; Mitral Valve Insufficiency - physiopathology ; Mitral Valve Insufficiency - surgery ; Morbidity ; Mortality ; Patients ; Prospective Studies ; Treatment Outcome ; Ventricular Remodeling
ispartofThe American heart journal, 2013, Vol.165 (5), p.761-769
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6Hehrlein, Christoph, MD
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8Sénéchal, Mario, MD
9Douglas, Pamela, MD
10Bertrand, Olivier F., MD, PhD
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0Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: Results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial
1The American heart journal
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descriptionObjectives PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). Background Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. Methods Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. Results A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm2 or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m ( P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm2 ( P = .001) and less prior history of myocardial infarction ( P = .02), coronary artery bypass surgery ( P = .03), and ischemic MR ( P = .04). Conclusions Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.
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29Mitral Valve Insufficiency - surgery
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34Treatment Outcome
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titleTreatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: Results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial
authorMacHaalany, Jimmy, MD ; Bilodeau, Luc, MD ; Hoffmann, Rainer, MD ; Sack, Stefan, MD ; Sievert, Horst, MD ; Kautzner, Josef, MD ; Hehrlein, Christoph, MD ; Serruys, Patrick, MD, PhD ; Sénéchal, Mario, MD ; Douglas, Pamela, MD ; Bertrand, Olivier F., MD, PhD
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5Cardiology
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7Care and treatment
8Echocardiography
9Female
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11Heart attacks
12Heart failure
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15Heart Failure - physiopathology
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19Laboratories
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23Mitral Valve - physiopathology
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abstractObjectives PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). Background Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. Methods Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. Results A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm2 or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m ( P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm2 ( P = .001) and less prior history of myocardial infarction ( P = .02), coronary artery bypass surgery ( P = .03), and ischemic MR ( P = .04). Conclusions Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.
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