Publications by authors named "Kjell Arne Rein"

26 Publications

  • Page 1 of 1

Single-centre first experience with transapical transcatheter mitral valve replacement with an apical tether: factors influencing screening outcomes.

Interact Cardiovasc Thorac Surg 2019 05;28(5):695-703

Department of Cardiothoracic Surgery, Oslo University, Oslo, Norway.

Objectives: Transcatheter mitral valve replacement has recently been introduced as an alternative treatment option for severe mitral regurgitation. We present our single-centre first experience with screening and implantation outcomes.

Methods: Twenty-five patients with mitral regurgitation grades 3 and 4 were screened based on study inclusion/exclusion criteria, echocardiography and computed tomography imaging. All patients were evaluated by the centre's Heart Team, followed by the Tendyne's internal screening process. Patients who failed the screening criteria were considered for alternative treatments.

Results: Of the 25 patients screened for transcatheter mitral valve replacement, 14 patients failed screening and 11 patients passed. The patients who failed screening were more often older, were women and were smaller in stature than those who passed screening. The main reason for patients to fail screening changed during the study from large annular dimensions to a small predicted neo-left ventricular outflow tract. Eight of the 11 patients who passed screening were treated using the Tendyne device, and 3 patients required alternate treatments due to urgency including 1 MitraClip procedure and 2 surgical repairs. Of the 14 patients who failed the screening, 5 patients had open surgery (4 patients received mitral valve repair and 1 mitral valve replacement). All 8 patients who underwent the Tendyne procedure were successfully treated without mortality during the observation time.

Conclusions: Transcatheter mitral valve replacement is an effective and safe treatment for well-selected patients with symptomatic mitral regurgitation. For patients who fail the screening process, the MitraClip procedure or open surgical valve repair are feasible.
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http://dx.doi.org/10.1093/icvts/ivy343DOI Listing
May 2019

Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTE†.

Eur J Cardiothorac Surg 2019 Apr;55(4):737-743

Department of Internal Medicine III (Cardiology and Angiology) UKSH, Campus Kiel, Kiel, Germany.

Objectives: There is lack of data regarding the longer-term outcomes of patients undergoing transaortic (TAo) transcatheter aortic valve implantation (TAVI). We aimed to provide a contemporary snapshot of the types and frequencies of events in the year following TAo-TAVI.

Methods: The Registry of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) is a multicentre, European, prospective, observational registry of aortic stenosis patients undergoing TAo-TAVI. Patients were grouped according to the composite end point death, myocardial infarction, stroke/transient ischaemic attack, major vascular complications, life-threatening bleeding, acute kidney injury (AKI) and/or cardiovascular rehospitalization.

Results: Two hundred and fifty-three patients with a mean age of 81.5 ± 5.8 years were included, of whom 89 (35.2%) patients met the composite end point (the event group) and 164 (64.8%) patients did not (the event-free group). New York Heart Association (NYHA) class III/IV (85.2% vs 71.8%, P = 0.017), Canadian Cardiovascular Society angina class III/IV (22.6% vs 11.4%; P = 0.021), pulmonary disease (32.6% vs 18.9%; P = 0.015) and renal insufficiency (15.7% vs 3.0%; P < 0.001) were more common in the event group. At 1 year, the most common event was death (19.1%), followed by AKI stage II or III (14.7%). The baseline renal insufficiency was the strongest independent predictor of composite end point achievement [odds ratio (OR) 7.55, 95% confidence interval (CI) 2.33-24.56], followed by NYHA class III/IV (OR 2.316, 95% CI 1.06-5.06) and pulmonary disease (OR 2.91, 95% CI 1.45-5.85). Pulmonary disease was also an independent predictor of 1-year mortality (OR 3.01, 95% CI 1.34-6.75).

Conclusions: Long-term outcomes after TAo-TAVI appear to be similar to those for TAVI via other non-transfemoral access routes. Awareness of characteristics associated with poorer outcomes may aid patient selection and identification of those requiring closer post-procedural monitoring.

Clinical Trial Registration Number: ClinicalTrials.gov identifier: NCT01991431.
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http://dx.doi.org/10.1093/ejcts/ezy333DOI Listing
April 2019

Balloon-expandable transaortic transcatheter aortic valve implantation with or without predilation.

J Thorac Cardiovasc Surg 2018 03 2;155(3):915-923. Epub 2017 Nov 2.

Institut Hospitalier Jacques Cartier, Massy, France.

Objective: It has been reported that balloon aortic valvuloplasty immediately before transfemoral or transapical transcatheter aortic valve implantation has mostly little to no clinical value. We aimed to provide data on the need for balloon aortic valvuloplasty in patients undergoing transaortic transcatheter aortic valve implantation.

Methods: Patients undergoing transaortic transcatheter aortic valve implantation with the Edwards SAPIEN XT (Nyon, Switzerland) or 3 transcatheter heart valve were prospectively included at 18 sites across Europe. In the present analysis, we compare the periprocedural and 30-day outcomes of patients undergoing conventional (+ balloon aortic valvuloplasty) versus direct (- balloon aortic valvuloplasty) transaortic transcatheter aortic valve implantation.

Results: Of the 300 patients enrolled, 222 underwent conventional and 78 underwent direct transaortic transcatheter aortic valve implantation. Peak and mean transvalvular gradients were improved in both groups with no significant difference between groups. Procedural duration, contrast agent volume, and requirement for postdilation were also comparable. A trend toward fewer periprocedural complications was evident in the direct group (3.9% vs 11.3%; P = .053), with significantly lower rates of permanent pacemaker implantation (0% vs 5.0%; P = .034). Balloon aortic valvuloplasty omission had no significant effect on any of the 30-day safety and efficacy outcomes, including Valve Academic Research Consortium-2 composite end points (early safety events: 22.7% vs 17.4%, odds ratio, 1.17, 95% confidence interval, 0.53-2.62; clinical efficacy events: 20.5% vs 18.7%, odds ratio, 1.14, 95% confidence interval, 0.51-2.55).

Conclusions: For many patients, balloon aortic valvuloplasty predilation seems to have little clinical value in transaortic transcatheter aortic valve implantation using a balloon expandable transcatheter valve and may result in a higher rate of periprocedural complications, particularly in terms of permanent pacemaker implantation.
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http://dx.doi.org/10.1016/j.jtcvs.2017.10.071DOI Listing
March 2018

EVALUATION OF OCCUPATIONAL RADIATION DOSE IN TRANSCATHETER AORTIC VALVE IMPLANTATION.

Radiat Prot Dosimetry 2018 Apr;179(1):9-17

Department of Diagnostic Physics, Oslo University Hospital, Oslo, Norway.

Occupational doses during fluoroscopy in interventional procedures vary largely (Kim et al. (Occupational radiation doses to operators performing cardiac catheterization procedures. Health Phys. 2008;94:211-227)). In transcatheter aortic valve implantation, the operators' positions and use of radiation shielding are particularly related to the entry choice on the patient's heart. This study evaluates how occupational doses depend on operator positioning during transfemoral and transaortal access. Occupational dosimetric readings were collected with electronic dosemeters on two cardiothoracic surgeons and one cardiologist during 31 procedures. The findings were significantly higher body doses and eye lens doses to the surgeons during transaortal access compared to transfemoral access. The median equivalent eye lens dose per procedure received by the cardiologists was 0.05-0.06 mSv; hence, the cardiologists should wear protective eye wear to prevent reaching the proposed annual dose limit of 20 mSv to the eye lens. Surgeons ought to use protective eye wear as well, and should only perform a restricted number of transcatheter aortic valve implantations with transaortal access annually.
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http://dx.doi.org/10.1093/rpd/ncx184DOI Listing
April 2018

Morbidity outcomes after surgical aortic valve replacement.

Open Heart 2017;4(1):e000588. Epub 2017 Apr 13.

Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.

Objective: In patients with mild to moderate operative risk, surgical aortic valve replacement (SAVR) is still the preferred treatment for patients with severe symptomatic aortic stenosis (AS). Aiming to broaden the knowledge of postsurgical outcomes, this study reports a broad set of morbidity outcomes following surgical intervention.

Methods: Our cohort comprised 442 patients referred for severe AS; 351 had undergone SAVR, with the remainder (91) not operated on. All patients were evaluated using the 6-minute walk test (6MWT), were assigned a New York Heart Association class (NYHA) and Canadian Cardiovascular Society class (CCS), with additional scores for health-related quality of life (HRQoL), cognitive function (Mini-Mental State Examination (MMSE)) and myocardial remodelling (at inclusion and at 1-year follow-up). Adverse events and mortality were recorded.

Results: Three-year survival after SAVR was 90.0%. SAVR was associated with an improved NYHA class, CCS score and HRQoL, and provoked reverse ventricular remodelling. The 6MWT decreased, while the risks of major adverse cardiovascular events (death, non-fatal stroke/transient ischaemic attack or myocardial infarction) and all-cause hospitalisation (incidence rate per 100 patient-years) were 13.5 and 62.4, respectively. The proportion of cognitive disability measured by MMSE increased after SAVR from 3.2% to 8.8% (p=0.005). Proportion of patients living independently at home, having attained NYHA class I, was met by 49.1% at 1 year. Unoperated individuals had a poor prognosis in terms of any outcome.

Conclusion: This study provides knowledge of outcomes beyond what is known about the mortality benefit after SAVR to provide insight into the morbidity burden of modern-day SAVR.
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http://dx.doi.org/10.1136/openhrt-2017-000588DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5471875PMC
April 2017

Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry.

Interact Cardiovasc Thorac Surg 2017 11;25(5):757-764

St. Thomas' Hospital, London, UK.

Objectives: Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information.

Methods: ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed.

Results: Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P = 0.045) and after implantation (13.6% vs 30.1%; P = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P = 0.21), TAVI-related (0.8% vs 4.7%; P = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P = 0.049), and there was a lower rate of moderate-to-severe paravalvular regurgitation (0.8% vs 5.1%; P = 0.050) in the SAPIEN 3 group.

Conclusions: Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis.

Clinicaltrials.gov Identifier: NCT01991431.
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http://dx.doi.org/10.1093/icvts/ivx159DOI Listing
November 2017

Single centre experience with transapical transcatheter mitral valve implantation.

Interact Cardiovasc Thorac Surg 2017 08;25(2):177-184

Department of Cardiothoracic and Thoracic surgery, Oslo University Hospital, Oslo, Norway.

Objectives: A transcatheter heart valve technique can be used in failed mitral valve repairs with annuloplasty rings, deterioriated bioprostheses and in mitral annular calcification, all serving as 'docking stations' for balloon-expandable valves. Specially designed transcatheter mitral valve platforms are used in ongoing studies for native mitral valve regurgitation. We present our single centre experience with transcatheter mitral valve implantation-transapical approach procedures in eleven patients.

Methods: Eleven patients were treated between 2011 and 2016. They had severe mitral regurgitation due to either failed repair annuloplasty rings (N = 6), failed bioprostheses (N = 2) or in the native valve (N = 3), all at high risk for open mitral valve surgery. Three different types of transcatheter valves were used: (1) the SAPIEN XT/SAPIEN 3, (2) the Lotus valve and (3) a Tendyne transcatheter mitral valve. Computed tomography reconstruction, echocardiography, 3D printing and bench tests were done in the preoperative evaluation and procedural planning. Transapical approach access was performed via a left minithoracotomy.

Results: Implantation success was 100% with no left ventricular outflow tract obstruction. Good haemodynamics and improved New York Heart Association class were demonstrated in all patients. One patient died before 30 days due to sepsis. One patient had a valve thrombosis when switching from Coumadin to new oral anticoagulant and had a second valve implanted into the first one as a 'valve-in-valve' procedure.

Conclusions: The transapical approach is a safe and straight forward procedure for accessing the mitral valve. 'Transcatheter aortic valve implantation' prostheses may be used in redo surgery due to an already sufficient 'docking station'. These specially designed new prostheses may be beneficial for addressing mitral valve regurgitation, but are still under evaluation. Anticoagulation is mandatory.
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http://dx.doi.org/10.1093/icvts/ivx038DOI Listing
August 2017

Transaortic transcatheter aortic valve implantation as a first-line choice or as a last resort? An analysis based on the ROUTE registry.

Eur J Cardiothorac Surg 2017 May;51(5):919-926

Institut Hospitalier Jacques Cartier, Massy, France.

Objectives: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed alternative to transapical (TA) or transfemoral (TF) TAVI. We aimed to analyse the effectiveness and safety of TAo-TAVI as a first line approach and to compare it to patients receiving TAo-TAVI as a last resort, which is current practice.

Methods: ROUTE is a prospective, multicentre registry to assess the clinical outcomes of TAo-TAVI. Patients without contraindications for TA- and TF-TAVI (TAo-first) were compared to patients with contraindications for both of these access routes (TAo-last). Outcome analysis was based on VARC II defined clinical end-points.

Results: Three hundred and one patients were included, of which 224 patients met TAo-first and 77 TAo-last criteria. The valve was delivered and catheter retrieved successfully in all patients. In the TAo-first group, rates of conversion to open surgery and requirement for a second valve were low and not different compared to TAo-last patients (1% vs. 3%, P  = 0.46 and 1% vs. 3%, P  = 0.46, respectively). This was also true for the rate of paravalvular regurgitation (≥ moderate: 4% vs. 3%). All-cause mortality at 30-days was 6% vs. 5% ( P  = 0.76), rates of stroke 2% vs. 0% ( P  = 0.24), pacemaker implantation (11% vs. 4%, P  = 0.093), and life-threatening bleeding 4% vs. 3% ( P  = 0.70). Valve safety (both 85%, P  = 0.98) and clinical efficacy (80% vs. 82%; P = 0.73) did not differ between groups.

Conclusions: Although comparative data to TA and TF procedures were not available in the present analysis, findings suggest that TAo may be considered not only as a last resort strategy when classical access routes are deemed unfeasible, but also as a potential first-line option, with only low rates of paravalvular regurgitation and permanent pacemaker implantation.

Clinicaltrials.gov: NCT01991431.
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http://dx.doi.org/10.1093/ejcts/ezw406DOI Listing
May 2017

Transcatheter Aortic Valve Replacement Using Transaortic Access: Experience From the Multicenter, Multinational, Prospective ROUTE Registry.

JACC Cardiovasc Interv 2016 09;9(17):1815-22

Institut Hospitalier Jacques Cartier, Massy, France.

Objectives: The Registry of the Utilization of the TAo-TAVR approach using the Edwards SAPIEN Valve (ROUTE) was established to assess the effectiveness and safety of the use of transaortic (TAo) access for transcatheter aortic valve replacement (TAVR) procedures (NCT01991431).

Background: TAVR represents an alternative to surgical valve replacement in high-risk patients. Whereas the transfemoral access route is used commonly as the first-line approach, transapical access is an option for patients not suitable for transfemoral treatment mainly due to anatomic conditions. TAo-TAVR has been shown to be a viable alternative surgical access route; however, only limited data on its effectiveness and safety has been published.

Methods: ROUTE is a multicenter, international, prospective, observational registry; data were collected from 18 centers across Europe starting in February 2013. Patients having severe calcific aortic stenosis were documented if they were scheduled to undergo TAo-TAVR using an Edwards SAPIEN XT or a SAPIEN 3 valve. The primary endpoint was 30-day mortality. Secondary endpoints were intraprocedural or in hospital and 30-day complication rates.

Results: A total of 301 patients with a mean age of 81.7 ± 5.9 years and an Society of Thoracic Surgeons score of 9.0 ± 7.6% were included. Valve success was documented in 96.7%. The 30-day mortality was 6.1% (18/293) (procedure-related mortality: 3.1%; 9 of 293). The Valve Academic Research Consortium-2 defined complications included myocardial infarction (1.0%), stroke (1.0%), transient ischemic attack (0.3%), major vascular complications (3.4%), life-threatening bleeding (3.4%), and acute kidney injury (9.5%). In 3.3% of patients, paravalvular regurgitation was classified as moderate or severe (10 of 300). Twenty-six patients (8.8%) required permanent pacemaker implantation.

Conclusions: TAo access for TAVR seems to be a safe alternative to the transapical procedure.
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http://dx.doi.org/10.1016/j.jcin.2016.06.031DOI Listing
September 2016

Edwards SAPIEN XT in Native Stenotic Mitral Valve, Open Technique on Cardiopulmonary Bypass: An Option, But Safe?

Innovations (Phila) 2016 Jul-Aug;11(4):288-90

From the Department of Thoracic and Cardiovascular Surgery, Rikshospitalet, Oslo University Hospital, Oslo, Norway.

A 73-year-old woman underwent open mitral valve replacement with the transcatheter Edwards SAPIEN XT valve (Edwards Lifesciences, Corp, Irvine, CA USA) on cardiopulmonary bypass in a native, stenotic mitral valve. Because of left ventricular outflow tract obstruction, the patient died 25 days after implantation. There are previous reports of transcatheter valve implantation in native mitral valve with procedural success. However, in one case report, the patient died 10 days postoperatively.
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http://dx.doi.org/10.1097/IMI.0000000000000272DOI Listing
May 2017

Intraoperative improvement in left ventricular peak systolic velocity predicts better short-term outcome after transcatheter aortic valve implantation.

Interact Cardiovasc Thorac Surg 2016 Jan 13;22(1):5-12. Epub 2015 Oct 13.

The Intervention Centre, Rikshospitalet, Oslo University Hospital, Oslo, Norway

Objectives: Left ventricular function is expected to improve after transcatheter aortic valve implantation due to the acute reduction in afterload, but does not occur in all patients. We hypothesized that the immediate intraoperative response in systolic left ventricular longitudinal motion during the procedure could be a predictor of short-term outcome.

Methods: Sixty-four patients treated with transcatheter aortic valve implantation for severe aortic stenosis were included. Transoesophageal 4- and 2-chamber echocardiograms were obtained immediately prior to and ∼15 min after valve implantation. Patients were defined as responders if their average left ventricular longitudinal peak systolic velocity increased by ≥20% from the preimplantation value and was related to the 3-month outcome.

Results: Thirty-five patients were classified as responders, with an increase in the intraoperative longitudinal peak systolic velocity from an average of 2.2 ± 0.8 to 3.1 ± 1.1 cm/s (P < 0.001); the velocity was unchanged in the remaining 29 patients, who averaged 2.4 ± 1.1 cm/s. There were significantly fewer adverse cardiac events in the responder group at the 3-month follow-up (20 vs 45%, P = 0.03) and the New York Heart Association class was significantly better in the responders compared with non-responders. Responders had a significant reduction in N-terminal probrain natriuretic peptide levels [243 (113-361) vs 163 (64-273), P = 0.004] at the 3-month follow-up, whereas non-responders did not [469 (130-858) vs 289 (157-921), P = 0.48].

Conclusions: An immediate improvement in the longitudinal peak systolic velocity during the transcatheter aortic valve implantation procedure predicted a better short-term outcome and may be useful in identifying patients who are at risk of a less favourable outcome after transcatheter aortic valve implantation.
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http://dx.doi.org/10.1093/icvts/ivv277DOI Listing
January 2016

Concomitant transatrial valve-in-valve in pulmonal and tricuspid position.

Catheter Cardiovasc Interv 2015 Nov 3;86(5):897-902. Epub 2015 Feb 3.

Department of Cardiothoracic Surgery, Guys and St. Thomas' Hospital, London, United Kingdom.

Transcatheter valve implantation in the pulmonary valve has been established as a valuable treatment option for patients with conduit failure in the right ventricular outflow tract, most often with the use of the Melody valve. Transcatheter valve-in-valve (VIV) implantation in the tricuspid position is restricted to single case reports, most often with the implantation of the Edwards SAPIEN valve. A 67 years old male with carcionoid syndrome and previously implanted bioprosthesis in the pulmonary and tricuspid valve now presented with worsening symptoms due to degeneration of both bioprostheses. The risk of new open surgery was deemed to high. We report of the first transatrial double VIV implantation using the balloon expandable Edwards SAPIEN XT in pulmonary and tricuspid position.
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http://dx.doi.org/10.1002/ccd.25843DOI Listing
November 2015

Direct aorta ascending approach in transcatheter aortic valve implantation.

Innovations (Phila) 2014 Jan-Feb;9(1):1-9

From the Department of Cardiothoracic Surgery, Oslo University Hospital, Oslo, Norway.

Objective: Direct aorta ascending approach [transaortic approach (TAo)] is a new access way for transcatheter aortic valve implantation (TAVI) to be used in patients with peripheral vascular disease and as an alternative to transapical approach.

Methods: Both the Edwards SAPIEN and CoreValve systems were used. Depending on the position of the ascending aorta, the relation to the sternum, the brachiocephalic vein, vein grafts, and left and right internal mammary artery grafts from previous heart surgery, either right minithoracotomy or left ministernotomy was selected. Computed tomographic scan with reconstruction was applied for this decision making. A hybrid operating room was used with echocardiographic and fluoroscopy guidance.

Results: We have done 30 procedures via the aorta ascendens. The mean age of the patients was 80 years, and 18 were men. The mean Logistic EuroSCORE of 33 reflects the comorbidities. More than half of the patients had coronary vessel disease and had undergone coronary artery bypass graft; 20% had abdominal aortic aneurysm. The mean ejection fraction was 41%, and the patients were in New York Heart Association class III to IV. The mean gradient was 50 mm Hg, and the mean valve area was 0.7 cm. The mean valve size was 28 mm. The use of Edwards SAPIEN versus CoreValve was 50%/50%, and thoracotomy versus sternotomy was 9 versus 21. All procedures were done successfully, but one patient had a periprocedural valve-in-valve implantation. Twenty-two patients were extubated in the operation room. The patients stayed in the intensive care unit for one night. Six patients were reoperated on. One patient had a postoperative balloon aortic valvuloplasty. The overall survival was 81% (follow up, 1-18 months).

Conclusions: Access design is an important issue in TAVI. When central approach is needed, TAVI-TAo is safe. For patients with low ejection fraction, the TAVI-TAo is preferred to the TAVI-transapical. The cannulation technique of the aorta is well known for cardiothoracic surgeons, and the method is feasible both for the Medtronic CoreValve and the Edwards SAPIEN valve, either via right minithoracotomy or ministernotomy to obtain the best coaxial alignment. It seems easier to position the bigger valves more precisely via this central approach.
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http://dx.doi.org/10.1097/IMI.0000000000000046DOI Listing
November 2014

Transapical valve-in-valve-in-ring for stenotic mitral valve repair.

Innovations (Phila) 2013 Sep-Oct;8(5):376-80

From the *Department of Cardiothoracic Surgery, Oslo University Hospital, Oslo, Norway; and †Kardiologisk Klinikk, Rigshospitalet, Copenhagen, Denmark.

A 53-year-old woman, previously treated with irradiation and chemotherapy for Hodgkin lymphoma, was referred for redo valve surgery. She had had a pacemaker implantation and undergone coronary bypass surgery, mitral valve repair with a Carpentier-Edwards 28-mm Physio-annuloplasty ring, as well as a mechanical tricuspid valve replacement and a transfemoral CoreValve 26-mm implantation. She had cardiac cachexia, pleura effusion, and a failed mitral valve repair with stenosis. She was judged inoperable for open surgery but suitable for a transapical valve-in-valve implantation on partial femorofemoral bypass. A 26-mm Edwards SAPIEN XT aortic valve inversely mounted on the Ascendra + delivery catheter was balloon expanded into the Physio ring. During expansion, the introducer sheath remained too deep into the left ventricle and rotated the SAPIEN valve upward to the left atrium, creating the onset of a new mitral regurgitation and retaining the stenosis. Another Edwards SAPIEN XT 26-mm valve was then positioned into the first valve in a "valve-in-valve-in-ring" tandem configuration. Both valves were supported by the Physio ring. The stenosis and the regurgitation were thereafter eliminated.
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http://dx.doi.org/10.1097/IMI.0b013e3182a6940bDOI Listing
September 2014

Transcatheter valve-in-ring implantation after failure of surgical mitral repair.

Eur J Cardiothorac Surg 2013 Jul 25;44(1):e8-15. Epub 2013 Mar 25.

Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard Hospital, Paris, France.

Objectives: Redo surgery after failed mitral valve repair may be high risk, or contraindicated in patients with comorbidities. Because of this high risk, other interventional possibilities like transcatheter valve implantation might be of benefit. We report our experience with transcatheter mitral valve-in-ring implantation (TVIR) in high-risk patients after failure of surgical ring annuloplasty.

Methods: From January 2010 to February 2012, following a multidisciplinary discussion, 17 high-risk patients underwent TVIR using Edwards SAPIEN XT prostheses, via either a transvenous transseptal (n = 8), or a transapical approach (n = 9).

Results: Patients were aged 70 ± 16 years, in New York Association classes III/IV. Their mean logistic EuroSCORE was 36 ± 17% and mean Society of Thoracic Surgeons risk score 13 ± 9%. The mean time interval between surgery and repair failure was 7 ± 3 years. Annuloplasty rings were semi-rigid in 14 cases, flexible in 2, and rigid in 1. Manufacturers ring diameters were 26 mm in 4 patients, 27 mm in 1, 28 mm in 9, 30 mm, 31 mm and 34 mm in 1. The predominant failure mode was regurgitation in 12 cases and stenosis in 5. SAPIEN XT diameters were 26 mm in 15 patients, 23 mm and 29 mm in 1. Procedural success rate was 88% (15/17). Emergency surgery was needed in 1 patient due to acute dislodgement of the ring. The degree of mitral regurgitation was reduced to none or mild in all but 2 patients; final mean gradient was 7 ± 3 mmHg. Thirty-day survival was 82% (14/17 patients). At last follow-up (13 ± 5 months), survival rate was 71% (12/17).

Conclusions: These preliminary results suggest that TVIR is feasible, with low operative risk, and may provide short-term clinical and haemodynamic improvement in selected high-risk patients with failure of mitral ring annuloplasty.
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http://dx.doi.org/10.1093/ejcts/ezt155DOI Listing
July 2013

Transapical 29-mm Edwards SAPIEN-XT aortic valve in a 34-mm mitral annuloplasty ring.

Innovations (Phila) 2012 Jul-Aug;7(4):290-4

Department of Cardiothoracic Surgery, Oslo University Hospital, 0424 Oslo, Norway.

A 71-year-old woman with severe congestive heart failure and failed mitral valve repair was referred for surgery. Because of her low ejection fraction, a valve-in-ring procedure was suggested. There was a great difference in the given size for the 34-mm Carpentier-Edwards-Physio-Ring and the biggest available transcatheter valve of 29 mm from Edwards. Therefore, we did a "bench test." We expanded a 29-mm Edwards SAPIEN-XT aortic valve in a 34-mm Carpentier-Edwards-Physio-Ring. It fitted well and turned out circular with good coaptation of the leaflets. Thereafter, a successful transapical mitral valve-in-ring implantation on cardiopulmonary bypass was performed, and additional leads for cardiac resynchronization was placed.
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http://dx.doi.org/10.1097/IMI.0b013e31826d5cd0DOI Listing
June 2013

Innovative technology-transcatheter aortic valve implantation: cost and reimbursement issues.

Scand Cardiovasc J 2012 Dec 18;46(6):345-52. Epub 2012 Oct 18.

Department of Cardiothoracic Surgery, University of Oslo, Oslo, Norway.

Objective: Transcatheter aortic valve implantation (TAVI) offers a new treatment option for patients with severe symptomatic aortic valve stenosis, classified as "inoperable". The purpose of the study was to reveal the association between ascertained hospital costs with the actual patient Diagnosis-Related Group (DRG).

Method: We examined 50 consecutive patients who underwent either transapical TAVI, (TAVI-TA) or transfemoral TAVI (TAVI-TF) with the Edwards SAPIEN valve and CoreValve(®) between September 2009 and August 2011.

Results: Fourty-nine patients had successful valve deployment. Seven patients died within 30 days of the operation. The mean length of hospital stay for TAVI-TA was 199 hours (range 77-362), and the mean costs for TAVI-TA were 55,690 US$. For TAVI-TF the mean length of hospital stay was 170 hours (range 49-276) and the mean costs were 52,087 US$.

Conclusion: There was no significant difference between TAVI-TA and TAVI-TF patient characteristics. There was a significant discrepancy between actual hospital costs and the current Norwegian DRG reimbursement for the TAVI procedure. This discrepancy can be partly explained by excessive costs related to the introduction of a new program with new technology. Costly innovations should be considered in price-setting of reimbursement for novel technology.
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http://dx.doi.org/10.3109/14017431.2012.724177DOI Listing
December 2012

Long-term follow-up of patients operated with the symmetry proximal connector device.

Innovations (Phila) 2011 Jan;6(1):15-6

From the Intervention Centre, Oslo University Hospital, Institute for Hospital Medicine, University of Oslo, Oslo, Norway.

Objective: : The Symmetry proximal connector device was introduced as a facilitator for construction of proximal anastomosis in coronary bypass surgery. Use of the connector made it unnecessary to clamp the ascending aorta. Early results were promising, but a controlled study performed in our center demonstrated poor angiographic patency of saphenous veins attached with the connector. The objective of this study was to investigate long-term clinical results in patients operated with connector or traditional suture technique.

Methods: : At a minimum of 5 years after surgery, medical records of 46 patients who had undergone off-pump coronary bypass with Symmetry (n = 23) or traditional suture (n = 23) were examined, and the patients were interviewed personally by phone. Patients were asked about the presence of angina pectoris, hospital admission for cardiac conditions, or the need for new interventions. The Norwegian population registry was used to document survival status.

Results: : Two control patients and five Symmetry patients died during the observation period (P = 0.414). Seven Symmetry and one control patient required reintervention (P = 0.015). Of the patients who were interviewed, 8 of 19 Symmetry patients suffered from angina and none of 20 control patients (P = 0.003).

Conclusions: : Patients who were operated with the Symmetry connector device have a high chance of having cardiac ischemia in the intermediate to long term after surgery, despite of relatively frequent reintervention. Patients operated with this connector requires close clinical follow-up.
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http://dx.doi.org/10.1097/IMI.0b013e31820c7e80DOI Listing
January 2011

Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study.

Heart 2007 Apr 25;93(4):500-5. Epub 2006 Oct 25.

Department of Cardiothoracic Surgery, Trondheim University Hospital, Trondheim, Norway.

Objective: The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis.

Methods: From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography.

Results: 30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from complications and linearised rates were as follows: 96.9 (1.6)% survival; 94.7 (1.3)% (2.06 patients/year) thrombo-embolism; 99.4 (0.6)% (0.4 patients/year) bleeding; 98.8 (0.9)% (0.8 patients/year) non-structural valve dysfunction; 98.8 (0.9)% (0.8 patients/year) reoperation. Valvular mean pressure gradients ranged from 16 (3) mm Hg for size 19 to 7 (2) mm Hg for size 27 and the corresponding effective orifice areas ranged from 1.2 (0.25) to 3.2 (0.66) cm(2). In all, left ventricular mass significantly decreased (p<0.001) and fractional shortening increased (p<0.001) from postoperative to 1 year echocardiography.

Conclusions: Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use.
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http://dx.doi.org/10.1136/hrt.2005.086041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1861508PMC
April 2007

Clinical and radiologic outcome of off-pump coronary surgery at 12 months follow-up: a prospective randomized trial.

Ann Thorac Surg 2006 Jun;81(6):2089-95

Department of Thoracic and Cardiovascular Surgery, Rikshospitalet University Hospital, Oslo, Norway.

Background: After more than a decade of experience with off-pump coronary bypass surgery, still no consensus exists concerning its benefit on clinical outcome compared to the on-pump technique. In this 12-month follow-up, we compare off-pump and on-pump surgery on the appearance of graft patency, myocardial function, and clinical outcome.

Methods: One hundred twenty patients were randomized to off-pump or on-pump coronary surgery. Angiography was performed intraoperatively, at 3 and 12 months. Global myocardial function was estimated by magnetic resonance imaging (MRI) preoperatively and 12 months postoperatively, as well as functional class and stress testing.

Results: After 12 months internal mammary artery patency was 94% in the off-pump group and 96% in the on-pump group. Vein graft patency was 80% and 87%, respectively. No statistically significant difference between the two groups existed. There were no differences in exercise capacity improvement and attenuation of symptoms between the groups.

Conclusions: At 12-months follow-up, off-pump coronary bypass surgery provided the same angiographic graft patency as the on-pump technique. Improvement in functional class and exercise capacity was the same in both groups.
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http://dx.doi.org/10.1016/j.athoracsur.2005.12.003DOI Listing
June 2006

A life-threatening complication of the Nuss procedure for pectus excavatum.

Ann Thorac Surg 2006 Jan;81(1):370-2

Department of Thoracic and Cardiovascular Surgery, Rikshospitalet University Hospital, Oslo, Norway.

We describe a delayed, life-threatening complication in a boy operated on using the Nuss-procedure 2 months earlier. On admittance he was in shock with cardiac tamponade. An immediate needle aspiration of blood from the pericardium was done before a median sternotomy. The Nuss-bar was removed, and we identified a 1.5-cm laceration in the adventitial layer of the ascending aorta as the source of bleeding. The tear was closed, and the patient had an uneventful recovery. Careful positioning of the bar is necessary to avoid complications. Measures must be taken postoperatively to confirm that the steel bar does not rotate.
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http://dx.doi.org/10.1016/j.athoracsur.2004.09.008DOI Listing
January 2006

Cerebral microembolization during off-pump coronary artery bypass surgery with the Symmetry aortic connector device.

J Thorac Cardiovasc Surg 2005 Dec;130(6):1581-5

Department of Neurology, Rikshospitalet University Hospital, Oslo, Norway.

Objective: The use of aortic connector systems for proximal vein grafts in off-pump coronary artery bypass grafting might minimize aortic manipulation by eliminating the need for partial aortic clamping. The objective of this study was to asses whether use of a Symmetry connector (St Jude Medical, Inc, St Paul, Minn) reduced intraoperative cerebral embolization.

Methods: Thirty-two consecutive patients underwent off-pump coronary artery bypass grafting. Sixteen patients received at least one mechanical proximal vein graft anastomosis with a Symmetry aortic connector system. Sixteen patients representing the control group underwent operations with standard suturing techniques using partial aortic clamping. During surgical intervention, all patients were monitored continuously with multifrequency transcranial Doppler scanning, which detected and differentiated cerebral emboli.

Results: There were significantly more cerebral emboli in the Symmetry group (median, 36) compared with the control group (median, 11; P = .027). This was due to a higher number of gaseous emboli in the Symmetry group than in the control group (median, 27 vs 8; P = .014), whereas there was no significant difference regarding the number of solid emboli (median, 7 vs 3; P = .139).

Conclusion: Use of a Symmetry connector system during proximal vein graft anastomosis increased the number of emboli to the brain compared with a standard technique in coronary bypass surgery without cardiopulmonary bypass.
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http://dx.doi.org/10.1016/j.jtcvs.2005.08.015DOI Listing
December 2005

Detection of ischemia and new insight into left ventricular physiology by strain Doppler and tissue velocity imaging: assessment during coronary bypass operation of the beating heart.

J Am Soc Echocardiogr 2004 Dec;17(12):1225-33

Department of Cardiology and the Interventional Centre, Rikshospitalet University Hospital, Oslo, Norway.

Background And Objectives: Detection of myocardial ischemia in humans by strain Doppler and tissue velocity imaging was validated in a novel, experimentally designed study model during coronary bypass operation of the beating heart.

Methods: Assessment of ischemia was made with an opened chest and pericardium inherent in the operative procedure. Longitudinal strain and tissue velocity of interventricular septal regions were measured by transesophageal echocardiography during occlusion of the left anterior descending coronary artery (LAD).

Results: Unexpectedly, baseline velocities demonstrated that the apical and basal septum moved toward each other during systole. This occurred when the apex was dislodged from the pericardial sac to obtain access to the LAD, without any change in strain. The preceding motion of all septal regions toward the apex was reestablished after the heart was repositioned within the pericardium. In 16 patients with antegrade LAD flow, strain Doppler detected ischemia during LAD occlusion by disclosing systolic lengthening of the apical septum ( P <.01) and reduced shortening of the mid septum ( P <.05). The location and degree of ischemic changes coincided with the concomitant deterioration of wall motion. Tissue velocity changed in the basal and mid septum ( P <.05) but not in the apical region, explained by tethering effects and the distinctive motion pattern at baseline. There was no evidence of ischemia by invasive hemodynamic measures. In 7 patients with retrograde LAD flow, there were no significant changes in strain or tissue velocity measurements during LAD occlusion.

Conclusions: Strain by Doppler is a sensitive means for detecting myocardial ischemia, also capable of correctly localizing the ischemia, as opposed to tissue velocity assessment. However, velocity measurements provided new physiological information by disclosing the normal longitudinal motion of the heart to be dependent on the pericardial sac enveloping the apex, irrespective of the structural integrity of the pericardium.
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http://dx.doi.org/10.1016/j.echo.2004.07.014DOI Listing
December 2004

Intraoperative and intermediate-term angiographic results of coronary artery bypass surgery with Symmetry proximal anastomotic device.

J Thorac Cardiovasc Surg 2004 Nov;128(5):718-23

Interventional Center, Rikshospitalet, Oslo, Norway.

Objective: The objective of this study was to investigate the patency in saphenous vein coronary bypass grafts in which the proximal anastomoses were performed with automatic connector devices or with a traditional suture technique.

Methods: Forty-six patients underwent coronary artery bypass grafting without cardiopulmonary bypass by using one thoracic graft and one or more saphenous vein grafts. Grafts were attached to the aorta with a Symmetry connector (St Jude Medical, Inc, St Paul, Minn) in 23 patients, and partial occlusion of the aorta and sutured anastomoses were used in 23 other patients. Grafts were studied intraoperatively with transit time flowmetry and angiography and revised if necessary. Angiography was repeated after 3 to 5 months.

Results: Intraoperative graft patency did not differ between the 2 groups. Follow-up angiography demonstrated excellent thoracic graft patency. Vein graft patency decreased to 50% in the Symmetry group, whereas it was 90% in the suture group ( P = .01). Twenty-five percent of the Symmetry grafts had significant stenosis in the connector.

Conclusion: Saphenous vein grafts anastomosed to aorta with the Symmetry proximal connector have low intermediate patency compared with those with traditionally sutured anastomoses. We do not recommend the routine use of this device in coronary artery bypass operations.
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http://dx.doi.org/10.1016/j.jtcvs.2004.07.001DOI Listing
November 2004

Intraoperative angiography leads to graft revision in coronary artery bypass surgery.

Ann Thorac Surg 2004 Aug;78(2):502-5; discussion 505

The Interventional Centre, Rikshospitalet University Hospital, N-0027 Oslo, Norway.

Background: Graft anastomosis quality in coronary artery bypass surgery can be assessed by intraoperative angiography. The aim of the present study was to quantify the on-table revision rate initiated by intraoperative angiography.

Methods: Intraoperative angiography was carried out in 186 patients undergoing coronary artery bypass surgery, with a total of 427 grafts. The operation was performed on-pump in 34%, off-pump through a sternotomy in 49%, and as a minimally invasive direct coronary bypass grafting (MIDCAB) procedure in 17%. The angiography was performed intraoperatively while the patients were still in general anesthesia, with the possibility for on-table revision. Follow-up angiography was carried out after a mean of 346 days.

Results: Eighteen of 427 grafts (4.2%) were revised due to the findings at intraoperative angiography. Revision rate after on-pump surgery was 1.1%, after off-pump through a sternotomy 6.4%, and after MIDCAB 6.5%. In 6 patients the lesions were located at the distal anastomoses and in 12 patients in the conduit. All but one was successfully revised, and at 1-year follow-up all these 17 grafts were patent.

Conclusions: Intraoperative angiography saves a potential number of grafts that otherwise could have been occluded. An increased implementation of intraoperative quality assessment in coronary artery bypass surgery can lead to improved outcome.
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http://dx.doi.org/10.1016/j.athoracsur.2004.03.004DOI Listing
August 2004

Clinical and Angiographic Outcome of Coronary Surgery with and without Cardiopulmonary Bypass: A Prospective Randomized Trial.

Heart Surg Forum 2004 Jan 1;7(1):37-41. Epub 2004 Jan 1.

Department of Thoracic and Cardiovascular Surgery, Rikshospitalet, Oslo, Norway.

Abstract Background: Off-pump coronary artery bypass surgery has emerged as an alternative technique to traditional onpump surgery. The aim of this randomized study was to compare perioperative morbidity and mortality and intraoperative and short-term graft patency in off-pump and on-pump coronary artery bypass grafting. Methods: One hundred twenty patients were randomized for coronary revascularization with or without cardiopulmonary bypass. In all patients grafts and anastomoses were monitored with transit time Doppler ultrasonography and angiography. Angiography was repeated 3 months after the procedure in 115 of the patients. Results: Angiography 3 months postoperatively revealed that internal mammary artery patency was 98% in both groups. Vein graft patency was 83% in the off-pump group and 91% in the on-pump group, a difference that was not statistically significant. One perioperative death was recorded in each group. Two strokes were recorded in the on-pump group, none in the off-pump group. Conclusion: In this prospective, controlled study, perioperative and short-term outcome of off-pump coronary surgery equaled that of on-pump surgery.
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January 2004
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