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Ann Thorac Surg 2009;88:90-94. doi:10.1016/j.athoracsur.2009.03.070
© 2009 The Society of Thoracic Surgeons
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Right arrow Valve disease

Original Articles: Adult Cardiac

Unexpected Complications of Transapical Aortic Valve Implantation

Nawwar Al-Attar, FRCS, PhDa, Walid Ghodbane, MDa, Dominique Himbert, MDb, Céderic Rau, MDa, Richard Raffoul, MDa, David Messika-Zeitoun, MDb, Eric Brochet, MDb, Alec Vahanian, FRCP, MDb, Patrick Nataf, MD, FETCSa,*

a Department of Cardiovascular Surgery, Bichat – Claude Bernard Hospital, Paris, France
b Department of Cardiology, Bichat – Claude Bernard Hospital, Paris, France

Accepted for publication March 25, 2009.

* Address correspondence to Dr Nataf, Department of Cardiac Surgery, Bichat Hospital, 46 rue Henri Huchard, Paris, 75018, France (Email: patrick.nataf{at}bch.aphp.fr).

Presented at the Poster Session of the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26–28, 2009.


Drs Nataf, Himbert, Brochet, and Vahanian disclose that they have financial relationships with Edwards Lifesciences.

 

   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background: Recent series have reviewed the results of transapical aortic valve implantation (TAVI). However, specific problems of this new procedure are not well-described. Unexpected complications due to the procedure and their management are reported.

Methods: Eighteen patients underwent TAVI using the Edwards Sapien bioprosthesis (Edwards Lifesciences Inc, CA) between September 2007 and June 2008 due to contraindications of conventional surgery (n = 5) or high operative risk (n = 13). The system was introduced through 2 purse string sutures in the apex under echocardiographic and fluoroscopic control.

Results: The implantation success rate and initial procedural success were 100%. There was no intraoperative death and no stroke. During the procedure, two cases of ventricular fibrillation consequent to rapid pacing were treated by cardioversion. Acute mitral regurgitation due to traction of the subvalvular apparatus by the guidewire and acute aortic regurgitation from pressure on a bioprosthesis cusp by the guidewire were diagnosed by transesophageal echocardiography and reversed by the removal of the guidewire. Another case of aortic regurgitation was due to incomplete deployment of the bioprosthesis and was managed by a "valve after valve" procedure. Two patients died on postoperative day 2 from left ventricular failure. In one patient the postmortem study showed, despite correct implantation of the bioprosthesis, a hematoma of the septum with a small ventricular septal defect. The total in-hospital death was 27.7% (5 patients). There was no periprocedural bleeding but in one patient delayed rupture of the apex (36 hours after the procedure) necessitated emergency surgery. A false aneurysm of the apex appeared 3 months after surgery in another patient. Closure of the apex was performed through sternotomy and cardiopulmonary bypass with an uneventful follow-up.

Conclusions: The TAVI is associated with incidents and complications different to those encountered in conventional aortic valve surgery. Recognizing their existence contributes to elucidating their mechanisms and to propose solutions to avoid or treat them.

Transcatheter aortic valve implantation (TAVI) was first attempted in man in 2002 [1]. Initially this procedure was reserved for compassionate cases where multiple comorbidities precluded surgical replacement of the aortic valve under cardiopulmonary bypass [2]. The TAVI can be performed either by retrograde approach through a vascular access, usually the common femoral artery, or by an antegrade transapical approach through the apex of the left ventricle by an anterolateral thoracotomy. In either case TAVI should be performed in high volume centers by teams experienced in the management of high-risk patients for aortic valve disease [3].

Nevertheless, being a new procedure, TAVI is subject to complications not previously experienced by surgical or medical teams. We report our experience in transapical TAVI with unexpected incidents and complications due to the procedure and ways to prevent, overcome, or manage them.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
Between September 2007 and June 2008, 18 patients with severe symptomatic aortic stenosis (AS) underwent transapical TAVI. Thirteen patients underwent transapical TAVI due to contraindications of conventional surgery, namely from porcelain aorta and (or) redo surgery with patent coronary artery bypass grafts and (or) extensive chest radiotherapy (radiodermatitis and myocardial damage), while 5 patients underwent TAVI because aortic valve replacement was considered high risk due to severe comorbidities in the absence of a technical surgical contraindication (Table 1). In all patients the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences Inc., CA), which consists of 3 bovine pericardial leaflets mounted within a tubular stainless-steel stent, was employed. The prosthesis exists in 2 sizes; 23 mm and 26 mm. Seven patients (39%) had a size 23 mm prosthesis. The first 7 patients were included in the Placement of Aortic Transcatheter Valve-European (PARTNER EU) study and the protocol was approved by the local ethics committee.


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  		Table 1 Patient Characteristics
 
Patients were selected by a multidisciplinary team, including clinical cardiologists, echocardiographists, interventional cardiologists, cardiac surgeons, and anesthesiologists according to a strategy in which the transfemoral approach was the first option, leaving the transapical approach for patients refused both surgery and the transfemoral approach. The selection process involved a multidisciplinary consultation between treating physicians taking into consideration the risk of surgery, evaluation of life expectancy, and quality of life, as well as assessment of the feasibility and exclusion of contraindications for TAVI. The European System for Cardiac Operative Risk Evaluation (EuroSCORE) and Society of Thoracic Surgeons (STS) score offered quantitative assessment and together with clinical judgment helped to establish whether patients were at high risk for surgery [4]. This approach allowed us to take into account risk factors (such as chest radiation, previous aortocoronary bypass with patent grafts, porcelain aorta, etc) that are not covered in scores but were seen in our patients. The predictive risk scores (EuroSCORE and STS) do not capture all relevant variables and are known to have limitations in this particular group of patients [5, 6]. All patients were included in a prospective registry. Patients underwent complete clinical examination, transthoracic transesophageal echocardiography (TEE), coronary angiography, aortic and femoroiliac angiography, and multislice computed tomography. Transapical (TA) TAVI was performed through a left anterolateral minithoracotomy under general anesthesia, with fluoroscopic and TEE guidance. External defibrillator pads were positioned away from the potential site of thoracotomy. Heparin was administered at 110 IU/kg b.w., intravenously. The site of the incision was determined by TTE prior to prepping the patient. To facilitate surgical conversion, a sheath was inserted into both the femoral artery and vein to allow immediate cannulation of the femoral vessels and establishment of cardiopulmonary bypass. The pericardium was opened and suspended to the thoracic wall. Pacing wires were inserted and tested to induce rapid ventricular pacing. The left ventricular apex was then punctured through 2 purse-string sutures. The valve was crimped just prior to implantation. A sheath (initially 33 French, n = 7, then 26 French, n = 11) was introduced in the left ventricle and the prosthesis introduced by the Ascendra system (Edwards Lifesciences) in an antegrade fashion, positioned within the aortic annulus, and then delivered by balloon inflation under rapid ventricular pacing. At the end of the procedure, intravenous protamine was administered at an equivalent dose. Cardiopulmonary bypass was available on standby in the operating room in case of the need for a bail-out procedure [7]. During hospital stay, clinical and echocardiographic data were obtained and all adverse events were prospectively recorded. After discharge, clinical and echocardiographic follow-up was obtained in all survivors at 1 to 3 months, 6 months, and 1 year. Patient characteristics are shown in Table 1.

Outcomes were described according to the guidelines for reporting mortality and morbidity after cardiac interventions [8]. Procedural success is defined as valve implantation in the correct position, with good immediate hemodynamic result and no major complications.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
Initial procedural success for TAVI was 100% with all valve implanted within the aortic annulus. There was no intraoperative mortality. We did not observe stroke after recovery from anesthesia in any patient.

All patients survived the procedure and death occurred in the hospital in 27.7% (5 patients). In-hospital death was early (postoperative day 2) in 2 patients (11%). One patient (5.5%) died from intractable arrhythmia and acute left ventricular failure. The postmortem study showed, despite correct implantation of the bioprosthesis, a hematoma of the septum with a small ventricular septal defect (Fig 1). The other patient developed respiratory distress after extubation and died from subsequent cardiogenic shock despite intraaortic balloon pump implantation. Further in-hospital mortality included 3 patients; including 1 death from septic shock, 1 death from sepsis and multiorgan failure due to leg ischemia requiring amputation, and 1 death from the drug rash, eosinophilia, and systemic (DRESS) syndrome at 18, 39, and 60 days, respectively.


Figure 1
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  		Fig 1. Postmortem study showing appropriate seating of the valve. The arrows point to the hematoma in the septal wall in relation with the stent of the prosthesis and a small defect in the interventricular septum. (VSD = ventricular septal defect.)

 
Eight patients (44.4%) had deterioration of the renal function demonstrated by an increase in serum creatinine postoperatively. In 1 patient (5.5%) a pace-maker was implanted to treat permanent atrioventricular block. Two patients (11%) had respiratory infections. In 1 patient it was associated with the DRESS syndrome. An intraaortic balloon pump was implantated in 3 patients (16%) for ventricular assistance in cardiogenic shock.

After discharge, 2 further patients died from noncardiac causes (pneumonia and sepsis at 60 days in 1 patient and geriatric cachexia at 65 days in the other). The overall mortality in this series was 38% (7 patients).

Specific Incidents and Complications to TAVI
Acute mitral insufficiency
In 1 patient, immediately after introduction of the guidewire into the left ventricular cavity, the patient became hemodynamically instable. The TEE demonstrated severe mitral regurgitation (MR). The guidewire was entangled with the mitral valve chordae and, while the team was focusing on the attempts to pass the aortic valve, traction on the guidewire induced acute MR. Retraction and repositioning of the guidewire through a different angle avoiding the mitral chordae was sufficient to establish mitral competence and hemodynamic stability.

Ventricular fibrillation
Rapid ventricular pacing induced ventricular fibrillation in 2 patients requiring cardiac massage and external cardioversion with restoration of a sinus rhythm.

Aortic insufficiency
In 14 patients, moderate intraprosthetic regurgitation was observed immediately after valve deployment. Pressure of the stiff guidewire on the cusps of the bioprosthesis induced valve incompetence. In an additional patient, the guidewire completely jammed a cusp leading to severe intraprosthetic regurgitation. Removal of the guidewire within a catheter assured protection of the cusp from the wire and resolved the problem. There were no prosthesis malpositioning or conversion to on-pump surgical aortic valve replacement (AVR). However, in 1 patient immediately after implantation, severe aortic regurgitation due to incomplete deployment of the bioprosthesis, and in whom redilatation did not improve the degree of regurgitation, was eventually managed by implantation of a second prosthesis into the first one; "valve after valve," with satisfactory results. On follow-up, 1 patient had grade III aortic regurgitation without clinical consequences.

Bleeding-cardiac tamponades
There was no periprocedural bleeding. However, 2 cardiac tamponades required postoperative drainage. In 1 patient this was associated with the overzealous closure of the pericardium after the procedure. In the other, delayed rupture of the apex occurring 36 hours after the procedure subsequent to chest drain removal necessitated emergency surgery. The patient recovered from the surgery but the postoperative period was complicated by sepsis, multisystem organ failure, and death at day 39.

Vascular access complications
One patient had delayed rupture (after 1 week) of the femoral arterial access site with development of a false aneurysm that required subsequent surgical repair. Another patient with severe peripheral artery disease had thrombosis of the common iliac artery leading to leg ischemia and contributing to her death on the 18th postoperative day from septic shock.

Left ventricular false aneurysm
One patient developed a false aneurysm of the apex 3 months after the procedure (Fig 2). This was treated by surgical closure with uneventful recovery. The size of the introducing sheath was subsequently reduced from 33Fr to 26 Fr and no further complications related to the apical puncture were encountered.


Figure 2
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  		Fig 2. Computed tomographic scan shows false aneurysm of the apex of the left ventricle.

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
Surgical replacement of the aortic valve is the reference treatment of severe symptomatic aortic valve stenosis. This procedure has an established track record with an acceptable operative mortality, including in elderly patients [9–11]. It provides good long-term results and its complications are well-recognized. However, patients refused or are denied this surgery in 30% to 60% of cases despite satisfying the guidelines and fulfilling recommendations for surgical indications [12, 13]. In certain patients AVR is contraindicated due to technical complexities; namely a heavily calcified, atheromatous or porcelain aorta, and (or) surgery performed in patients with previous patent coronary artery bypass grafts and (or) extensive chest radiotherapy. Otherwise, patients treated by TAVI are those considered high risk for AVR due to the presence of severe comorbidities in the absence of a technical surgical contraindication. This new procedure is inevitably associated with novel or unknown complications. In our experience with transapical TAVI we report those we encountered and measures proposed to prevent, detect, and treat them.

The use of TEE was decisive in the diagnosis of valvular-related complications; namely, acute mitral insufficiency due to entanglement of the guidewire with the subvalvular apparatus and postimplantation intraprosthetic regurgitation from pressure of the guidewire on a valve cusp. Both situations were associated with significant hemodynamic disturbances and were entirely reversible by repositioning of the guidewire in the first case and its retraction in the second. Transesophageal echocardiography, particularly real time three-dimensional TEE, was of great benefit in the positioning of the prosthesis within the aortic annulus particularly when calcifications of the native valve were difficult to visualize. transesophageal echocardiography can also contribute to preserve renal function by avoiding repeat aortographies. After implantation, TEE evaluates the presence of leaks and the decision for further action. In 1 patient, a significant paraprosthetic leak was not improved by redilatation but could be corrected by the implantation of a second valve inside the previous one. Retrieval of the stiff guidewire within a catheter protects the valve cusps from damage and is followed by resolution of the intraprosthetic regurgitation from pressure on the cusp.

Rapid ventricular pacing is employed several times during the procedure to allow balloon valvuloplasty and implantation of the bioprosthesis. It can induce persistent ventricular fibrillation, as was the case in 2 patients. Because the access through the thoracotomy is extremely limited and can be impossible in redo patients, application of defibrillator pads on the chest beforehand is instrumental for external cardioversion. Care should be taken so as the pads do not lie in the path of the thoracotomy or other potential access areas and do not interfere with fluoroscopy. Collaboration with the anesthetist is essential. Drug manipulation and arterial pressure control can also considerably reduce the occurrence of ventricular fibrillation.

In our series, 3 patients with poor left ventricular function had implantation of an intraaortic balloon pump. We believe that this is of particular interest in patients with patent grafts of previous coronary artery bypass grafting. The choice of side for insertion of the balloon will depend on the work-up concerning the iliofemoral axes.

Complications related to the transapical puncture were observed in 2 patients. In the first patient, after an uneventful procedure, removal of the thoracic drains was immediately followed by severe bleeding. At reexploration, the apical sutures were intact but a tear adjacent to the purse string sutures in the left ventricle was responsible for the bleeding. Although repair was possible, the patient died after 39 days from sepsis and multiorgan failure. In the second patient, full recovery after the procedure was followed by the appearance of a pulsating mass in direct relation with the scar of the thoracotomy. This turned out to be a false aneurysm of the left ventricle and was corrected surgically (Fig 2) [14]. We advise the application of surgical glue, with or without a patch of pericardium, on the apex to reinforce the sutures. In all patients, the purse string sutures should be tightened without tension to avoid cutting through the myocardium.

Our list of complications with TAVI is not exhaustive. Several authors reported other complications such as occlusion of the coronary arteries, aortic dissection, valve migration or embolization, mitral regurgitation, and rupture of the aortic annulus [7, 15, 16], and other complications are yet to be described. The TAVI is a new procedure which implies learning from experience but also from mistakes. Several factors contribute to reducing the incidence of these complications as well as those cited above; progress in imaging by echocardiography and quality fluoroscopy is of significant importance. The learning curve and experience in the selection of patients should improve outcomes of TAVI.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
The first 7 patients were included in the PARTNER EU study and the valves were provided by Edwards Lifesciences Inc., CA as part of study protocol. All the other patients were treated with the financial support of the Assistance Publique-Hôpitaux de Paris.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

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  2. Cribier A, Eltchaninoff H, Tron C, et al. Early experience with percutaneous transcatheter implantation of heart valve prosthesis for the treatment of end-stage inoperable patients with calcific aortic stenosis J Am Coll Cardiol 2004;43:698-703.[Abstract/Free Full Text]
  3. Vahanian A, Alfieri OR, Al-Attar N, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Eur J Cardiothorac Surg 2008;34:1-8.[Abstract/Free Full Text]
  4. Al-Attar N, Himbert D, Descoutures F, et al. Transcatheter aortic valve implantation: selection strategy is crucial for outcome Ann Thorac Surg 2009;87:1757-1763.[Abstract/Free Full Text]
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  6. Dewey TM, Brown D, Ryan WH, Herbert MA, Prince SL, Mack MJ. Reliability of risk algorithms in predicting early and late operative outcomes in high risk patients undergoing aortic valve replacement J Thorac Cardiovasc Surg 2008;135:180-187.[Abstract/Free Full Text]
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