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Case Report
Percutaneous treatment of mitral regurgitation by MitraClipTM: report on the first two procedures in Brazil
Tratamento percutâneo da insuficiência mitral por MitraClip®: relato dos dois primeiros procedimentos no Brasil
Fabio S. Brito Jr.a,
Corresponding author
fabio.brito@einstein.br

Corresponding author. Hospital Israelita Albert Einstein, Intervenção Cardiovascular, Avenida Albert Einstein, 627/701, Morumbi, CEP: 05652-900, São Paulo, SP, Brazil.
, Alexandre Sicilianob, Claudio H. Fischera, Marcelo L. Vieiraa, Arnaldo Rabischoffskib, Fabio Papaa, Marcelo R. Fernandesb, Bernardino Tranchesi Jr.a, Paulo Dutrab, Marco A. Perina
a Hospital Israelita Albert Einstein, São Paulo, SP, Brazil
b Hospital Pró-Cardíaco, Rio de Janeiro, RJ, Brazil
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Mitral valve regurgitation is one of the most common acquired valvular diseases&#44; with a prevalence of approximately 7 to 10&#37; in the population aged &#62; 75 years&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2</span></a> The treatment of mitral regurgitation is traditionally based on clinical management with medications&#44; resynchronization&#44; and especially valve repair or valve replacement surgery&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> However&#44; despite guideline recommendations&#44; approximately 50&#37; of the patients are not treated surgically&#44; due to the presence of high surgical risk caused by advanced age&#44; left ventricular dysfunction&#44; or comorbidities&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> For this reason&#44; more recently the focus of research in this area has changed to the development of new and less invasive percutaneous devices for the treatment of mitral valve regurgitation&#46; Among them&#44; the MitraClip<span class="elsevierStyleSup">TM</span> system &#40;Abbott Vascular&#44; Redwood City&#44; USA&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41; is one of the most promising&#46; This device was approved for clinical use in Europe in March 2008&#44; and in the United States in October 2013&#46; To date&#44; more than 25&#44;000 patients have already benefited from this new treatment modality&#44; predominantly used in individuals at high surgical risk&#46; In Brazil&#44; the MitraClip<span class="elsevierStyleSup">TM</span> was approved for use in the end of 2014&#46; This report describes the first two procedures performed in Brazil for percutaneous treatment of mitral valve regurgitation using the MitraClip<span class="elsevierStyleSup">TM</span> device&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Case reports</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Case 1</span><p id="par0010" class="elsevierStylePara elsevierViewall">Female patient&#44; 97 years old&#44; admitted to Hospital Israelita Albert Einstein&#44; in S&#227;o Paulo &#40;SP&#41;&#44; due to sudden onset of congestive heart failure&#44; functional class IV&#46; Evaluations by transthoracic echocardiography &#40;TTE&#41; and subsequently by two-dimensional transesophageal echocardiography &#40;TEE&#41; showed severe mitral valve regurgitation &#40;4&#43;&#47;4&#43;&#41;&#44; due to mitral valve posterior leaflet prolapse &#40;segments P2 and P3&#41; associated with <span class="elsevierStyleItalic">chordae tendineae</span> rupture &#40;P2 segment&#41;&#44; resulting in extensive coaptation gap &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Figs&#46; 2</a>A to 2C&#41;&#46; The left atrium measured 48<span class="elsevierStyleHsp" style=""></span>mm&#44; and systolic blood pressure in the pulmonary artery was estimated at 53<span class="elsevierStyleHsp" style=""></span>mmHg&#46; Left ventricular function estimated by ejection fraction was normal&#46; Despite the prolonged hospital stay &#40;45 days&#41; for drug treatment optimization&#44; the patient had repeated episodes of acute pulmonary edema&#44; requiring intermittent intensive care and characterizing treatment resistance&#46; Due to the advanced age and comorbidities such as renal failure&#44; the medical team considered the surgical risk to be unacceptable&#46; Estimates of surgical mortality by logistic EuroSCORE and Society of Thoracic Surgeons &#40;STS&#41; risk score were 21&#46;1 and 18&#46;4&#37;&#44; respectively&#46; For this reason&#44; the percutaneous transseptal mitral valvuloplasty with MitraClip<span class="elsevierStyleSup">TM</span> device was indicated&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">The procedure was performed in a hybrid operating room on January 6&#44; 2015&#44; with the patient under general anesthesia&#44; and guided by three-dimensional TEE&#46; Heparin was administered at a dose of 10&#44;000 IU&#44; aiming to achieve an activated clotting time of 300 to 350<span class="elsevierStyleHsp" style=""></span>seconds&#46; Right femoral venipuncture was performed&#44; followed by transseptal puncture to obtain access to the left atrium&#46; A 24 F MitraClip<span class="elsevierStyleSup">TM</span> system catheter was introduced in the left atrium&#44; being directed to the mitral valve aided by fluoroscopy and three-dimensional TEE&#46; Several two- and three-dimensional TEE images were used to achieve adequate positioning of the clip&#44; perpendicular to the mitral commissure and over the regurgitation jet&#46; The clip was then advanced into the left ventricle&#44; with open arms&#46; Small additional adjustments in the clip position were guided by two- and three-dimensional TEE&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">When optimal positioning was obtained&#44; the clip was closed&#44; capturing equivalent portions of the mitral valve cusps &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>D&#41;&#46; An immediate reduction was observed in mitral regurgitation intensity&#44; from 4&#43;&#47;4&#43; to 2&#43;&#47;4&#43;&#44; observing the characteristic image of double mitral orifice &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Figs&#46; 2</a>E and 2F&#41;&#46; The mean transvalvular pressure gradient was 4<span class="elsevierStyleHsp" style=""></span>mmHg&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The clip was released from the delivery system&#46; The catheter was removed&#44; and hemostasis was achieved with a single Perclose ProGlide<span class="elsevierStyleSup">TM</span> &#40;Abbott Vascular&#44; Redwood City&#44; USA&#41; device applied to the puncture site in the femoral vein&#46; The procedure time &#40;clip time&#41; was 95<span class="elsevierStyleHsp" style=""></span>minutes&#46; A total of 50<span class="elsevierStyleHsp" style=""></span>mL of iodinated contrast was used to perform the baseline left ventriculography&#44; and after the procedure&#44; the patient was extubated and taken to the intensive care unit&#46; Worsening of renal function ensued&#44; requiring hemodialysis&#46; There was significant improvement in heart failure symptoms and the TTE performed 1 and 4 days after the procedure disclosed only mild mitral regurgitation &#40;1&#43;&#47;4&#43;&#41;&#46; On the fourth day after the intervention&#44; when the patient was progressing with significant heart failure symptom improvement&#44; she suddenly developed cardiogenic shock and respiratory failure due to massive pulmonary embolism&#44; and subsequently died&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Case 2</span><p id="par0030" class="elsevierStylePara elsevierViewall">Female patient&#44; 93 years old&#44; with hypertension&#44; diabetes&#44; obesity&#44; and hypothyroidism&#44; admitted to the emergency department of Hospital Pro-Card&#237;aco&#44; in Rio de Janeiro &#40;RJ&#41;&#44; with functional class IV progressive congestive heart failure&#44; which had started 45 days before&#46; On admission&#44; atrial fibrillation of unknown duration was observed&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Since 2006&#44; the patient had a diagnosis of mild mitral valve regurgitation due to prolapse&#46; Evaluations by TTE and subsequently by TEE performed during hospitalization disclosed the presence of severe mitral valve regurgitation &#40;4&#43;&#47;4&#43;&#41; with Coanda effect&#44; due to prolapse of both cusps&#44; associated with <span class="elsevierStyleItalic">chordae tendineae</span> rupture and A2 flail &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Figs&#46; 3</a>A to 3C&#41;&#46; The left atrium measured 50<span class="elsevierStyleHsp" style=""></span>mm&#44; and mean systolic blood pressure in the pulmonary artery was estimated at 50<span class="elsevierStyleHsp" style=""></span>mmHg&#46; Left ventricular function estimated by ejection fraction was normal&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">She was submitted to several unsuccessful attempts at clinical compensation&#44; despite the use of furosemide in continuous infusion&#44; in addition to inotropic &#40;milrinone&#41; and vasodilators&#46; The patient developed anasarca&#44; severe hyponatremia&#44; and hypokalemic metabolic alkalosis&#44; with continuous ultrafiltration and non-invasive ventilation being indicated&#46; Due to her advanced age and comorbidities such as renal failure&#44; she was considered as a high surgical risk patient by the medical team&#44; with mortality estimated by logistic EuroSCORE and STS risk score of 49&#46;3 and 48&#37;&#44; respectively&#46; For this reason&#44; percutaneous transseptal mitral valvuloplasty with the MitraClip<span class="elsevierStyleSup">TM</span> device was indicated&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">The procedure was performed in a hybrid operating room on January 16&#44; 2015&#44; with the patient under general anesthesia&#44; and guided by TEE&#46; The same technique described for the previous case was employed&#44; using a single clip&#46; An immediate reduction in mitral regurgitation intensity was obtained&#44; from 4&#43;&#47;4&#43; to 2&#43;&#47;4&#43;&#44; creating the double mitral orifice &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Figs&#46; 3</a>D to 3F&#41;&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The mean transvalvular pressure gradient was 4<span class="elsevierStyleHsp" style=""></span>mmHg&#46; After catheter removal&#44; hemostasis was obtained by manual compression&#46; The procedure time &#40;clip time&#41; was 70<span class="elsevierStyleHsp" style=""></span>minutes&#46; Iodinated contrast was not used in this procedure&#46; The patient was extubated and taken to the intensive care unit&#46; She had a slow&#44; but progressive recovery of spontaneous diuresis and stabilization of nitrogenous waste&#46; Weaning of vasoactive amines was carried out&#44; as well as of dialytic ultrafiltration&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The TEE performed 12 days after the procedure disclosed the presence of mild mitral regurgitation &#40;1&#43;&#47;4&#43;&#41;&#46; She was discharged 15 days after the mitral clip implantation&#44; walking with assistance and receiving oral medications&#58; amiodarone&#44; bisoprolol&#44; furosemide&#44; spironolactone&#44; rivaroxaban&#44; and pregabalin&#46; At the 6 month follow-up&#44; the patient was in functional class II&#46;</p></span></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Discussion</span><p id="par0060" class="elsevierStylePara elsevierViewall">The MitraClip<span class="elsevierStyleSup">TM</span> system was recently approved for clinical use in Brazil for the percutaneous treatment of functional or degenerative mitral valve regurgitation&#46; This device is based on the Alfieri procedure&#44; which creates a double orifice by placing a suture between the A2 and P2 segments of the mitral valve cusps&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> The randomized clinical trial EVEREST II &#40;Endovascular Valve Edge-to-Edge Repair Study&#41; demonstrated the safety and the efficacy of MitraClip<span class="elsevierStyleSup">TM</span> in selected cases&#44; with results maintained up to the 4 year follow-up&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6&#44;7</span></a> In that study&#44; the percutaneous repair was less effective to reduce the mitral regurgitation intensity than conventional surgical treatment&#46; However&#44; it was at least as safe as the surgical approach&#44; with equivalent rates of death&#44; infarction&#44; and stroke&#44; in addition to less need for blood transfusions&#46; Additionally&#44; the percutaneous treatment determined an equivalent improvement in heart failure symptoms and quality of life&#46;<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6&#44;7</span></a> Therefore&#44; it has become an excellent alternative for the treatment of mitral valve regurgitation in high surgical risk patients&#44; as in the two cases reported here&#44; representing a pioneering experience in Brazil&#46; These two patients had degenerative mitral regurgitation&#44; due to prolapse&#47;flail&#44; associated with <span class="elsevierStyleItalic">chordae tendineae</span> rupture&#46; In both cases&#44; a significant reduction in mitral regurgitation intensity was obtained with the use of a single clip&#46; The control echocardiograms performed within the first days after the procedure confirmed treatment efficacy&#44; with mild residual mitral regurgitation in the two patients&#46; The first patient died on the fourth day after the procedure due to massive pulmonary embolism&#44; probably due to prolonged immobility in the hospital bed&#44; despite the anticoagulation scheme started 2 days after the intervention&#46; There is no report in the literature of this complication associated with the mitral clip use&#46; The second patient showed significant clinical improvement and was in functional class II at the 8 month clinical follow-up&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">It is noteworthy that knowledge of mitral valve anatomy and the interaction between the interventional cardiologist and the echocardiographist are crucial to procedural success&#44; as this intervention is guided&#44; almost entirely&#44; by the images generated by the two- and three-dimensional TEE&#46; There is no need to use iodinated contrast with the MitraClip<span class="elsevierStyleSup">TM</span> system&#46; Hemorrhagic &#40;cardiac tamponade&#41; and embolic &#40;stroke&#41; complications&#44; although rare&#44; can occur due to transseptal puncture and left atrial manipulation with thick-caliber catheters&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> Constant checking of anticoagulation levels &#40;target activated clotting time between 300 and 350<span class="elsevierStyleHsp" style=""></span>seconds&#41; during the procedure is essential to prevent embolic complications&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Although in both cases reported here the MitraClip<span class="elsevierStyleSup">TM</span> was used for the treatment of degenerative mitral regurgitation&#44; its use for the treatment of functional mitral regurgitation is currently more frequent&#46;<a class="elsevierStyleCrossRefs" href="#bib0045"><span class="elsevierStyleSup">9&#44;10</span></a> Therefore&#44; the MitraClip<span class="elsevierStyleSup">TM</span> should be considered as an alternative to conventional surgical treatment in selected patients with degenerative or functional mitral regurgitation&#44; especially when the surgical risk is high due to advanced age and the presence of comorbidities or significant left ventricular dysfunction&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> Some anatomical conditions&#44; previously considered contraindications to the procedure in the EVEREST study&#44; have recently become more acceptable for the MitraClip<span class="elsevierStyleSup">TM</span> approach with the increasing experience of surgeons&#46; However&#44; some restrictions remain&#44; among which are&#58; significant calcification in the target location for clipping &#40;cusp edge&#41;&#59; degenerative lesions caused by rheumatic disease and endocarditis&#44; due to severe deformity and cusp lesion&#59; posterior cusp length &#8804; 7<span class="elsevierStyleHsp" style=""></span>mm&#59; coaptation gap &#62; 5<span class="elsevierStyleHsp" style=""></span>mm between the cusp borders&#59; gap &#8805; 10<span class="elsevierStyleHsp" style=""></span>mm between the borders of the anterior and posterior cusps caused by flail &#40;flail gap&#41;&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">In conclusion&#44; the two cases reported in this article have shown the great potential of this innovative technology for percutaneous treatment of mitral valve regurgitation&#44; which should be increasingly used in Brazil&#46; The near future will bring the introduction of other technologies&#44; including annuloplasty devices and prostheses for transcatheter prosthesis implantation&#44; expanding the horizons of interventional cardiology and benefiting an even greater number of patients&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Funding source</span><p id="par0080" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Conflicts of interest</span><p id="par0085" class="elsevierStylePara elsevierViewall">The authors declare no conflicts of interest&#46;</p></span></span>"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The MitraClip<span class="elsevierStyleSup">TM</span> system has been recently approved for clinical use in Brazil for percutaneous treatment of mitral valve regurgitation&#46; This device is based on the Alfieri surgical procedure&#44; creating a double orifice by bringing together the central segments of the two mitral valve cusps&#46; This report describes the first two procedures performed in Brazil using this device&#46; Two female patients considered to be at high surgical risk due to advanced age and presence of comorbidities were treated&#44; with degenerative mitral regurgitation due to prolapse&#47;flail&#44; associated with <span class="elsevierStyleItalic">chordae tendineae</span> rupture&#46; In both cases&#44; significant mitral regurgitation intensity reduction was obtained using the MitraClip<span class="elsevierStyleSup">TM</span>&#44; demonstrating the great potential of this innovative technology for the percutaneous treatment of mitral valve regurgitation&#46;</p></span>"
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        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">O sistema MitraClip<span class="elsevierStyleSup">&#174;</span> foi recentemente aprovado para uso cl&#237;nico no Brasil para o tratamento percut&#226;neo da insufici&#234;ncia valvar mitral&#46; Esse dispositivo se baseia na cirurgia de Alfieri&#44; criando um orif&#237;cio duplo pela uni&#227;o central das duas c&#250;spides da valva mitral&#46; Descrevemos aqui os dois primeiros procedimentos realizados em nosso meio utilizando esse dispositivo&#46; Tratam-se de duas pacientes do sexo feminino&#44; consideradas de alto risco cir&#250;rgico pela idade avan&#231;ada e pela presen&#231;a de comorbidades&#44; portadoras de insufici&#234;ncia mitral degenerativa por prolapso&#47;<span class="elsevierStyleItalic">flail</span> associado &#224; rotura de cordoalhas&#46; Nos dois casos&#44; obteve-se redu&#231;&#227;o expressiva da intensidade da regurgita&#231;&#227;o mitral com a utiliza&#231;&#227;o do MitraClip<span class="elsevierStyleSup">&#174;</span>&#44; demonstrando o grande potencial dessa tecnologia inovadora para o tratamento percut&#226;neo da insufici&#234;ncia valvar mitral&#46;</p></span>"
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                      "titulo" => "A prospective survey of patients with valvular heart disease in Europe&#58; The Euro Heart Survey on Valvular Heart Disease"
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        "texto" => "<p id="par0090" class="elsevierStylePara elsevierViewall">The authors would like to thank the technical support provided by Mr&#46; Flavio Toledo &#40;Abbott&#41;&#46; His extensive knowledge of the MitraClip<span class="elsevierStyleSup">TM</span> system significantly contributed to the success of these procedures&#46;</p>"
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ISSN: 22141235
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