Transapical treatment of paravalvular leaks in patients with a logistic euroscore of more than 15%

Transapical Treatment of Paravalvular Leaks inPatients With a Logistic Euroscore of More Than 15%:

Acute and 3-Month Outcomes of a‘‘Proof of Concept’’ Study

Martin J. Swaans,1 MD, Martijn C. Post,1 MD, PhD, H. A. Johan van der Ven,1 MD,Robin H. Heijmen,2 MD, PhD, Werner Budts,3 MD, PhD, and Jurien M. ten Berg,1* MD, PhD

Objective: We describe the short-term results of the patients who underwent transapicaltreatment of a paravalvular leak (PVL) in our centre. Background: Increasing experiencewith transapical aortic valve implantation has inspired us to explore this approach forprosthetic paravalvular leak reduction in high risk patients. Methods: All procedureswere performed in the catheterization laboratory under general anesthesia, using asmall anterolateral thoracotomy to expose the apex. Access through a 9-French sheathwas necessary to introduce the Amplatzer Vascular III plug. Three-dimensional trans-esophageal echocardiography (3D-TEE) was used to guide the operator and evaluatethe severity of regurgitation postimplantation. Results: In total seven consecutivepatients (mean age 72.8 6 5.6 years, 86% male) with a history of mitral valve (n 5 6) oraortic valve replacement and severe PVL, underwent transapical PVL reduction usingseven plugs in total (diameter 10–14 mm). Preprocedural median logistic EuroSCOREwas 28.5% (range 17.1–41.1%) and NYHA functional class was �3 in all patients. Theprocedure was successful in all patients, with a median fluoroscopic time of 18.7 min(range 10.1–29.6 min). Postprocedure 3D-TEE showed occlusion of PVL in threepatients, and significant reduction in three patients. Postprocedural complication wasa hematothorax requiring surgery in one patient. Median hospitalization duration afterthe procedure was 5 days (range 5–59 days). At 3-month follow-up one patient died,functional class and LDH did not differ significantly and there was a significantincrease in hemoglobin. Conclusions: Transapical paravalvular leak reduction might bea good or rather attractive alternative in high-risk patients for major re-do cardiacsurgery. VC 2012 Wiley Periodicals, Inc.

Key words: interventional cardiology; prosthetic valves; transesophageal echocardiography

INTRODUCTION

Prosthetic valve replacement surgery is performed in�210,000 patients annually worldwide. An importantclinical significant paravalvular leakage (PVL) willoccur in 3–12.5% [1].

Drug refractory heart failure or severe haemolysisrequiring repeated transfusions is an indication for sur-gical PVL closure [2]. However, redo-surgery is associ-ated with an in-hospital mortality rate between 6 and15%, which increases with the number of previoussternotomies [3–5].

Since 1992, the percutaneous PVL closure, usingboth the arterial and venous femoral access, had beenreported [6,7]. Although this transcatheter technique isassociated with low procedural mortality rates, in thetwo largest percutaneous series reported by the samegroup there was no peri-procedural mortality [8,9]. Thisapproach can be technically difficult and time consum-

ing, because of working with flexible guidewires insharp angle. In the previous mentioned studies a success-ful deployment of the device could be reached in about

1Department of Cardiology, St Antonius Hospital, Nieuwegein,The Netherlands2Department of Cardiothoracic Surgery, St Antonius Hospital,Nieuwegein, The Netherlands3Department of Cardiology, University Hospitals Leuven, Belgium

Conflict of interest: Nothing to report.

*Correspondence to: Jurien M. ten Berg, MD, PhD, Department of

Cardiology, St Antonius Hospital, Koekoekslaan 1, 3435 CM Nieu-

wegein, The Netherlands. E-mail: [email protected]

Received 12 October 2010; Revision accepted 27 May 2011

DOI 10.1002/ccd.23264

Published online 10 January 2012 in Wiley Online Library

(wileyonlinelibrary.com)

VC 2012 Wiley Periodicals, Inc.

Catheterization and Cardiovascular Interventions 79:741–747 (2012)

65% of the patients [8,9]. Furthermore, variable successrates (reduction in degree of leakage) were describedin previous case series, ranging from 30 to 100%, some-times after multiple interventions [7–15].

The transapical approach is a relatively novel tech-nique for reduction of peri-prosthetic leaks. This tech-nique was first described in an article by Lim et al.[16] followed by the series by Brown et al. [17] andNietlispach et al. [18] Direct ventricular access mighthave several benefits, which makes the interventiontechnically easier and shortens procedural time. In thisstudy we describe the short-term results of thisapproach in seven patients which is to our knowledgethe largest one using this approach.

METHODS

Patient Selection

All patients known with a paravalvular leakage andsymptoms of dyspnea, fatigue, severely reducedfunctional capacity (New York Heart Association ClassIII-IV) and/or a anemia due to hemolysis requiringfrequent transfusions underwent transthoracic- andtransesophageal echocardiography (both two- andthree-dimensional). The degree of leakage was classi-fied as: I (mild), II (mild to moderate), III (moderate),or IV (severe). The PVL grade III and IV were consid-ered to represent significant paravalvular leakage.These were discussed in our multi-disciplinary team ofcardiac surgeons and cardiologists. Patients were con-sidered to be eligible for the transapical approachwhen they were no candidates for surgery because of atoo high perioperative risk, according to the logisticEuroSCORE of more than 15%. In our centre there isno experience with percutaneous closure of PVL. Thestudy was approved by the local ethical committee.

Preprocedural Work-Up

Pre-procedural work up included physical examina-tion, assessment of functional capacity [New York HeartAssociation (NYHA) functional class] laboratorymeasurements [including haemoglobin (Hb), NT-probrain natriuretic peptide (NT-pro BNP), electrocardio-gram (ECG), transthoracic- and transesophageal echo-cardiography (both two- and three-dimensional)]. Allpatients were asked to fill out the Minnesota HealthQuestionnaire.

Procedure

All procedures were performed in the catheterizationlaboratory under general anesthesia. Prophylactic antibi-otics (cefazolin) were given prior to the procedure. Toexpose the cardiac apex a small anterolateral thoracot-omy was made by the thoracic surgeon, allowing direct

visualization for puncture and placement of a pursestring suture with pledgets. After puncturing the leftventricular apex a standard J-wire was advanced into theleft ventricle. The needle was exchanged for a 25 cm9-French sheath (Terumo, Elkton, MD). Through thissheath an angled 0.035-in. guide wire (Terumo, Elkton,MD) was introduced to cross the paravalvular leak.Once the guide wire was across the defect it wasexchanged over a 6-French catheter (Cordis, Miami, FL)for an extra support stiff Amplatz 0.035-in. J-wire (CookMedical, Bloomington, IN). This Amplatzer wire waspositioned in the left atrium to enable balloon sizingwith a low pressure balloon (Tyshak II, NuMED, Hop-kinton, NY) and guide catheter exchange. After placingthe sheath, intravenous heparin was administered tomaintain an activated clotting time of 300 msec. Real-time three dimensional transesophageal (3D-TEE) echo-cardiography (iE33-system and X7-2t probe, PhilipsMedical Systems, Best, the Netherlands), in addition tofluoroscopy, was used to assist the operator. The lowpressure balloon was placed in the PVL and inflated. Ifthere was full closure of the PVL on TEE the size of theleak was measured in two directions on fluoroscopy tochoose the right diameter of the closure device, allAmplatzer Vascular III plugs (AGA Medical Corpora-tion, Plymouth, MN). These fluoroscopy projectionswere perpendicular to each other and in most cases RAO30 and LAO 30 were used. Measurements were done onfluoroscopy since there was no possibility to do measure-ments on real-time 3D-TEE images. When the closuredevice was expanded in the paravalvular leak, simultane-ous evaluation of the PVL reduction and interferencewith the valve was done using TEE and fluoroscopy. If asignificant reduction in PVL was observed without valveinterference, the device was released. This is shown inFigs. 1 and 2. Otherwise the device was recaptured andrepositioned. After releasing the device, the PVL wasgraded, as the valve interference. Direct surgical closureof the puncture site followed by stitching of the skin,was carried out in all patients. The procedural timewas defined as the time frame from incision to closure ofthe thoracotomy. Before discharge, a transthoracic echo-cardiography was performed in all patients.

Statistical Analysis

Descriptive statistics were used to describe patientcharacteristics. Continuous variables with normal distri-bution were reported by mean � standard deviation. Ifnormal distribution was absent, median and range wereused. Number and percentages were used to report cat-egorical variables. A paired sampled t test was used tocompare variables preprocedural and at 3-months fol-low-up. All analysis was performed using SPSS soft-ware (SPSS, version 14.0 for Windows).

742 Swaans et al.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

RESULTS

Patient Characteristics

Seven patients (5 men, mean age 72.8 � 5.6 year)were included between October 2009 and March 2010.The mean logistic EuroSCORE was 28.5% (range 17.1–41.1%), the indication for PVL reduction was drugrefractory heart failure (n ¼ 1), severe haemolysisrequiring repeated blood-transfusions (n ¼ 3), or both(n ¼ 3). Different valves were implanted: two biopros-thetic mitral valves (Carpentier Edwards Perimount,Edwards Lifesciences, Irvine, California), one aorticbioprosthesis (St. Jude Epic, St. Jude Medical, St. Paul,MN), one tilting disc mechanical mitral valve (Medtronic

Hall, Medtronic, Minneapolis, MN), and three bileafletmechanical mitral valves (two Carbomedics [Austin,TX], one St. Jude Medical [St. Paul, MN]). The mediantime interval between valve replacement and paravalvu-lar leak procedure was 23 months, range 5–168 months.The baseline characteristics are shown in Table I.

Procedural, In-Hospital, and Follow-UpCharacteristics

The Amplatzer Vascular plug III was successfullyused in all patients. The median length of the plug was14 mm with a median diameter of 5 mm. The meanprocedural time was 77.5 � 11.3 min. A complete

Fig. 1. a. Midesophageal four chamber view pre-procedureshowing a severe paravalvular leakage at the posterolateralmargin of the bioprosthesis. b. Live three-dimensional (3D)atrial view of the mitral valve bioprosthesis pre-procedureshowing the large paravalvular defect at the posterolateralmargin of the bioprosthesis (arrow). LAA: left atrial append-age. c. Midesophageal four chamber view after placement ofthe Amplatzer Vascular plug showing only a trace paravalvular

leakage at the posterolateral margin of the bioprosthesis.d. Live three-dimensional (3D) atrial view of the mitral valvebioprosthesis post-procedure showing the Amplatzer Vascularplug (arrowhead) and a small remaining defect (arrow) wherethe trace of paravalvular leakage of Figure 1. c. originates.LAA: left atrial appendage. [Color figure can be viewed in theonline issue, which is available at wileyonlinelibrary.com.]

Transapical Paravalvular Leak Closure 743


closure could be reached in three patients, a minimalresidual PVL was present in three patients, and in onepatient a moderate PVL was still present after deviceplacement. However, a second device could not beplaced in the latter patient due to the small size of theresidual leakage. At 3-months follow-up a TEE wasperformed in five out of the seven patients. The grada-tion of the paravalvular regurgitation before, immedi-ately after the procedure, and at 3-months follow-up, isshown in Fig. 3.

A severe periprocedural complication occurred inour first patient (male, age 72 years). He developed anintrathoracic bleeding a few hours after the proceduredue to the puncture of an intercostal vein, whichrequired surgical intervention. Unfortunately he alsodeveloped pneumonia with exacerbation of his COPDduring hospitalization. A slow recovery of his concom-itant lung disease resulted in an extended duration ofhospitalization of 59 days. One patient developedshortness of breath due to pulmonary edema, but therewas a quick response on intravenous diuretics. Threeother patients needed a blood transfusion after the pro-cedure, because of worsening of their pre-proceduralanemic state. No device embolization occurred. Median

Fig. 2. Fluoroscopy images showing different proceduralsteps: a. Crossing of the paravalvular leak with a guidewire.b. Balloon sizing of the paravalvular leak with a low pressureballoon. The measurement of the PVL was 12 mm (white line).c. After release of the Amplatzer Vascular 14-mm plug.

TABLE I. Baseline Characteristics

Patients, n 7

Age (yr) 72.8 �5.6

Sex (%)

Male 5 (71)

Female 2 (29)

BMI (kg m�2) 24.3 �4.6

Blood pressure (mm Hg)Systolic 131.9 �11.1

Diastolic 76.9 �8.9

ECG, n (%)Sinusrythm 1 (14)

Atrial fibrillation 5 (71)

Pacemaker rhythm 1 (14)

Valve, n (%)

Aortic mechanic 0 (0)

Aortic biologic 1 (14)

Mitral mechanic 4 (57)

Mitral biologic 2 (29)

Laboratory

Hb (mmol l�1) 6.0 �0.9

LDH (U l�1) 1435 �1,290

NT-pro BNP (pg ml�1) 3882 �1,387

Log EuroSCORE (%) 28.5 �11.1

Minnesota Qol 45.3 �33.3

NYHA class 3.4 �0.5

All data are presented as mean � standard deviation or number with per-

centage (n (%)), N ¼ number, yr ¼ year, % ¼ percentage, BMI ¼ Body

Mass Index, kg m�2 ¼ kilogram per square meter, mm Hg ¼ millimetre of

mercury, Hb ¼ Hemoglobin, mmol l�1 ¼ millimol per litre, LDH ¼ lac-

tate dehydrogenase, U l�1 ¼ units per litre, NT-pro BNP ¼ N-terminal

prohormone of brain natriuretic peptide, pg ml�1 ¼ picogram per milli-

litre, Qol ¼ Quality of Life, NYHA ¼ New York Heart Association.

744 Swaans et al.


duration of hospitalization was 5 days (range 5–59).All patients were discharged on diuretics (100%) andmost of them (86%) on coumadin. The proceduralcharacteristics and the in-hospital complications aresummarized in Table II. The procedural characteristicsper patient are shown in Table III.

At 3-months follow-up the NYHA functional classimproved nonsignificantly (P ¼ 0.17). Preprocedurefour patients were in NHYA class III and three patientsin NYHA class IV. Three months after the procedureone patient was in NYHA class 1, one patient inNHYA class II, three patients in NYHA class III, andtwo patients in NYHA class IV. The haemoglobin levelincreased significantly from 6.1 � 0.9 mmol L�1 to6.6 � 1.0 mmol L�1 3 months after leakage reduction

(P ¼ 0.05). The LDH decreased nonsignificantly froma median of 841 U l�1 (259–3,865) to 484 U l�1 (256–2,303) 3 months after the procedure (P ¼ 0.07). Thesedata are presented in Table IV. The PVL reducedsignificantly shortly after device placement, thisimprovement remained 3 months after closure. This isshown in Fig. 3. At 3-months follow-up, one patientwho was in NYHA functional class IV died due toprogressive heart failure.

DISCUSSION

Although surgery continuous to be the technique ofchoice for repair of paravalvular leaks, this type of majorre-do surgery is associated with considerable morbidityin poor operative candidates [3–5]. Increasing experi-ence with transapical aortic valve implantation hasinspired us to explore this approach for the reduction ofPVLs as an alternative for patients with a high operativerisk. Also the availability of real-time 3D-TEE improvesthe visualization during the procedure, providing a pre-cise picture of the location, extent and morphology of thedefect [9]. Although 3D-TEE was helpful for

TABLE II. Procedural Characteristics

Plugs, n 7 (1:1)

Length (mm) 14 (10–14)

Diameter (mm) 5 (3–5)

Procedure (min)

Duration 77.5 �11.3

Fluoroscopy 18.7 �6.6

Hospitalization (days)ICU 1 (0–5)

Overall 5 (5–59)

Complications, n (%)Bleeding req. intervention 1 (14)

Anemia req. transfusion 3 (43)

Heartfailure 1 (14)

Medication at discharge n, (%)

Diuretics 7 (100)

Coumadin 6 (86)

ACE-inhibitor 2 (29)

Aspirin 2 (29)

All data are presented as mean � standard deviation or median with

upper and lower range. N ¼ number, mm ¼ millimetre, min ¼ minutes,

ICU ¼ Intensive Care Unit, % ¼ percentage, req. ¼ requiring, ACE-in-

hibitor ¼ Angiotensin converting enzyme-inhibitor.

Fig. 3. Severity of paravalvular regurgitation, before, post-procedure after deployment of an Amplatzer Vascular Plug IIIand at 3-months follow-up, as measured with color DopplerTEE.

TABLE III. Procedural Characteristics Per Patient

Site

defect

Defect

size

(mm)

Device

size

(mm)

PVL grade

preprocedure

PVL grade

postprocedure

PVL

grade

3 months

Patient 1 MV 10 14 4 1 1

Patient 2 MV 8 10 4 1 0

Patient 3 MV 12 14 3 0 *

Patient 4 AoV 9 12 4 0 1

Patient 5 MV 9 14 3 0 1

Patient 6 MV 12 14 4 2 0

Patient 7 MV 8 10 3 1 **

MV ¼ mitral valve, AoV ¼ aortic valve, mm ¼ millimetre, PVL ¼ para-

valvular leakage. * patient refused TTE, ** patient died due to progressive

heart failure.

TABLE IV. Follow-Up Characteristics

Before 3 months P value

NYHA (I/II/III/IV) 0/0/4/3 1/1/3/2 0.17

Hb (mmol l�1) 6.1 � 0.9 6.6 � 1.0 0.05

LDH (U l�1) 841 (259–3,865) 484 (256–2303) 0.07

EchocardiographyLVEDD (mm) 50.3 � 12.1 47.2 � 4.9 0.73

LVESD (mm) 33.3 � 15.6 29.6 � 7.5 0.85

LVEF (%) 48.0 � 12.1 49.0 � 11.4 0.67

RVSP (mm Hg) 34.8 � 17.3 24.2 � 7.4 0.43

All data are presented as mean � standard deviation or median with

upper and lower range, NYHA ¼ New York Heart Association, Hb ¼Hemoglobin, mmol l�1 ¼ millimol per litre, LDH ¼ lactate dehydrogen-

ase, U l�1 ¼ units per litre, LVEDD ¼ left ventricular end diastolic di-

ameter, mm ¼ millimetres, LVESD ¼ left ventricular end systolic diam-

eter, LVEF ¼ left ventricular ejection fraction, % ¼ percentage. RVSP

¼ right ventricular systolic pressure, mmHg ¼ millimetre of mercury.



visualization of the PVL it was not helpful during the de-cision of closure device size since real-time measure-ments of the PVL were not possible on the 3D-TEEimages. The short-term results of this study show a suc-cessful implantation of a closure device in seven consecu-tive patients with a clinical important PVL and a high op-erative risk.

Currently, percutaneous treatment of PVLs can besafely and effectively achieved using modification ofcurrently available equipment and devices [7]. How-ever, transfemoral interventions are complex, wherebyinstability of the delivery sheath makes crossing theparavalvular defects and deliverability of a closuredevice a technical challenge [1,7,10–12]. Different suc-cess rates using the transfemoral approach have beenreported. Four small studies described procedural suc-cess rates between 30 and 80% [11–13,15]. The twolargest series are reported by Cortes et al and Garcia-Fernandez et al. In the study by Cortes et al., in 17 outof the 27 patients (63%) the PVL could be passed,with a reduction of leakage in 50% of the remainingpatients. In the study Garcia-Fernandez et al. thedevice could be successfully deployed in 33 out of the52 patients (63.5%), with a reduction in the severity ofleakage in 17 out of the 33 patients (51.5%) [8,9]. Rea-sons for nonsuccessful procedures are impossibility tocross the PVL, inability to deploy the closure device,an important residual leak or interference of theoccluder with the prosthetic valve [7–15,17]. In ourstudy using only the transapical approach, a single pro-cedure was performed in every case and successfuldeployment of a closure device was possible in allpatients. Left ventricular access via mini-thoracotomyand guidewire crossing of the PVLs was remarkablefast and easy. Because of accurate balloon sizing andtrying different diameter of plugs, only one closuredevice was necessary in each patient.

The data of Pate et al. also shows that the transfe-moral technique is time consuming with a mean proce-dural time of �3 hr (range 120–304 min) and a meanfluoroscopy time of more than 1 hr. In our study, themean procedural time was only 77.5 � 11.3 min and amean fluoroscopy time of 18.7 � 6.6 min.

Although one postprocedural bleeding occurred,exposure of the heart via mini-thoracotomy and furtheraccess to the left ventricle seems to be rather safe inthis high risk patient group [18,19].

With our few experience, a transapical approachmight be easier and less time-consuming compared tothe transfemoral approach, resulting in a high rate ofprocedural success and a shorter procedural length.Increasing experience with transapical interventionsand assistance of modern imaging techniques, givesopportunities to explore other interventions in the sys-temic ventricle with this alternative approach [20].

Our study has several limitations: we only describe asmall number of patients with a short time of follow-up.We expect that the long term clinical follow-up resultsof this procedure will be roughly comparable with thatof transfemoral procedures. In which at 1-year follow-up25–30% has died, 20–45% still has haemolysis andpatients will improve median one grade in functionalclass [11,15]. However, we do not have experience usingthis latter approach for PVL reduction; therefore wewere not able to compare both techniques in our popula-tion. Indeed, the same closure devices are used incomparable paravalvular leaks. Reducing haemolysisand/or leakage should improve patient’s functional class.Clinical follow-up of our patients is necessary to explorelong term results of this procedure.

CONCLUSION

A transapical approach for paravalvular leak reduc-tion is a relatively new technique, which seems to behighly feasible with an acceptable rate of complica-tions in this high risk patient population. Direct leftventricular access to reduce a paravalvular leak, mightprove to be a good alternative for major re-do cardiacsurgery in high-risk patients.

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Transapical treatment of paravalvular leaks in patients with a logistic euroscore of more than 15%