Clin Res Cardiol DOI 10.1007/s00392-014-0698-y

REVIEW

Worldwide TAVI registries: what have we learned? Stephan Haussig • Gerhard Schuler Axel Linke



Received: 9 September 2013 / Accepted: 3 March 2014 Ó Springer-Verlag Berlin Heidelberg 2014

Abstract With a rapidly aging society, the number of patients with cardiovascular disease—in particular aortic stenosis—is progressively increasing. Although conventional aortic valve replacement remains the only treatment known to improve prognosis and symptoms in symptomatic patients with aortic stenosis, about one-third are still withhold from the life-saving therapy. Based on the compelling evidence of the randomized Placement of Aortic transcatheter valves (PARTNER) A and B cohort, TAVI is now considered standard of care for extreme risk and inoperable patients and is an alternative to surgery for highrisk patients with symptomatic aortic stenosis. However, these patients were super-selected, which does not reflect a clinical real-world situation. TAVI registries represent a real-world scenario, and therefore provide the evidence for the treatment of high-risk patients (regarding comorbidities and anatomical factors) in daily clinical life. The review will focus on the recently published Edwards SAPIEN, Medtronic CoreValve and mixed (national) registries with the focus on short- and midterm outcome. These registries suggest that the growing experience of the operators with regard to patient selection, prevention, recognition and treatment of procedural complications together with the developments in valve design will improve the short-term results of TAVI. However, randomized trials in intermediate risk patients and data on long-term valve durability

This article is part of a series of 3 articles on TAVI that will be published in subsequent issues. S. Haussig  G. Schuler  A. Linke (&) Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Stru¨mpellstrasse 39, 04289 Leipzig, Germany e-mail: [email protected]

are a prerequisite before indications can be expanded to younger and lower risk patient population. Keywords Aortic Valve Stenosis  Medtronic CoreValve System  Edwards SAPIEN tissue heart valve  Surgical aortic valve replacement

Introduction: the importance of registries With a rapidly aging society, the number of patients with cardiovascular disease—in particular aortic stenosis—is progressively increasing [1]. Although conventional aortic valve replacement remains the only treatment known to improve prognosis and symptoms in symptomatic patients with aortic stenosis, about one-third are still withhold from the live-saving therapy [2, 3]. The reasons are multifactorial; patients are either not referred by the cardiologist, turned down by the surgeon because they are considered too ‘‘old’’ or too ‘‘frail’’ or the patients are afraid or think its not worth undergoing a cardiosurgical procedure at higher age [3, 4]. However, for those not considered for conventional aortic valve replacement, transcatheter aortic valve implantation (TAVI) represents an alternative treatment option. Since 2002, in which Dr. Alain Crebier performed the first TAVI in an inoperable patients with AS, the procedure has been used in more than 40 countries and 50,000 patients [5–26]. Based on the compelling evidence of the randomized Placement of Aortic transcatheter valves (PARTNER) A and B cohort, TAVI is now considered standard of care for extreme risk and inoperable patients and is an alternative to surgery for high-risk patients with symptomatic AS [27, 28]. However, the major drawback of PARTNER is the highly selected study cohort. The list of exclusion criteria contained 23 different scenarios

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disqualifying the patient from study participation despite of being extreme or high-risk, symptomatic and suffering from high-grade aortic stenosis [27, 28]. Some of the exclusion criteria are quite frequent in a real-world TAVI population, e.g., a recent myocardial infarction, treatment with a drug-eluting stent within the last 6 months, a preexisting prosthetic heart valve in any position, prosthetic ring, severe mitral annular calcification, or severe (greater than 3?) mitral regurgitation, blood dyscrasias, an ejection fraction below 20 %, a thrombus in the left atrial appendage, a stroke within the last 6 months, significant abdominal or thoracic aorta disease, including aneurysm, marked tortuosity, aortic arch atheroma, narrowing of the abdominal aorta, severe ‘‘unfolding’’ and tortuosity of the thoracic aorta or a femoral diameter below 7 mm. In a randomized controlled trial, it is reasonable to exclude these comorbidities or anatomical constraints to avoid confounding, but it makes it difficult to extend the major finding of the study to a real-world patient population. Nevertheless, these patients are captured by registries, which therefore provide the evidence for the treatment of high-risk patients (regarding comorbidities and anatomical factors) in daily clinical life. The Edwards SAPIEN and SAPIEN XT transcatheter heart valve (THV, Edwards Lifesciences Corp. Irvine, CA, USA) as well as the Medtronic CoreValve System (Medtronic Inc., Minneapolis, MN, USA) have been used in thousands of symptomatic patients with aortic stenosis [5–23, 29–40]. In addition, the Edwards SAPIEN valve received CE approval for the implantation into the pulmonary valve/artery [41, 42]. Moreover, the Accurate Valve (Symetis Inc., Ecublens, Switzerland) [43], the JenaValve (Jena Valve, Munich, Germany) [44] and the Engager Valve (Medtronic Inc., Minneapolis, MN, USA) [45] received CE approval for transapical treatment, whereas the recapturable and retrievable Portico Valve (SJM, St. Paul, MN, USA) [46] and the DirectFlow Valve (Santa Rosa, CA; USA) [47] is available for transvascular therapy of aortic stenosis since 2012. Current registries predominantly contain data on the Edwards SAPIEN/ SAPIEN XT and the CoreValve, since the other abovementioned transcatheter valves are just on the market for a few months [5–23]. This review gives an overview about Edwards, CoreValve and mixed registries. The last chapter summarizes, which questions have been already answered and which issues are still unresolved.

Edwards Registries The multicenter feasibility studies, like I-REVIEVE/ RECAST, TRAVERSE or REVIVAL, which were

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conducted between 2003 and 2009, were followed by large European and Canadian registries [8, 23, 48], (Table 1). These registries were proofing excellent hemodynamic results of transfemoral and transapical devices in the presence of a low short- and midterm mortality [14, 17]. The SOURCE Registry The findings from the above-mentioned studies and registries were extended by the SOURCE registry (cohort I), which contained data from 1,038 patients that were treated either transfemorally (TF, n = 463) or transapically (TA; n = 557) at 32 different European centers between November 2007 and January 2009. Due to more comorbidities, patients treated transapically had a higher European System of Cardiac Operative Risk Score, 29.1 % (EuroSCORE) as compared to the transfemoral cohort (25.7 %, p \ 0.001) [19, 20]. Procedural success was as high as 95.2 and 92.7 % in the presence of a 6.3 and 10.3 % 30-day mortality in the TF and TA cohort, respectively. Unfortunately, when the SOURCE I cohort was published in 2010, end points for transcatheter valve therapy studies were not defined yet, adverse events were site reported in the absence of an independent monitoring and more than 70 % of the centers had no history of TAVI experience [19, 20, 49, 50]. Despite these limitations and the higher 30-day mortality in comparison to PARTNER, the 1-year results continued to be promising with 72.1 and 81.1 % of the TA and TF cohort still being alive and in good clinical shape (73.5 % of the surviving patients were in NYHA class I or II) [19, 20, 27, 28]. Between February 2009 and December 2009, a second cohort of 1,269 patients was added, giving SOURCE a total size of 2,307 patients recruited at 37 sites in 14 countries [51, 52]. Again, patients treated transapically were more likely to have a history of coronary artery disease, previous myocardial infraction, previous coronary artery bypass grafting, mitral valve disease, previous aortic valve replacement, renal failure, peripheral artery occlusive disease, porcelain aorta and carotid stenosis, but they were younger and less likely to suffer from chronic heart failure. The higher frequency of comorbidities drove the EuroSCORE, which was higher in the TA (27.9 ± 16.1 %) as compared to the TF group (23.9 ± 14.2 %, p \ 0.05). There was no difference between TF and TA with regard to the occurrence of stroke (2.9 vs. 2.5 %), acute myocardial infarction (0.9 vs. 0.5 %) or need for permanent pacemaker implantation (6.7 vs. 7.1 %) at 30-day post-transcatheter aortic valve implantation. However, the TA cohort was more likely to experience acute renal failure/dialysis (6.7 vs. 1.8 %), bleeding complications (3.9 vs. 2.3 %), but less likely to suffer from total (2.0 vs. 11.3 %) or major (1.0 vs. 10.4 %) vascular complications. At 30 days, 1 year and 2 years, 92.5 and

Clin Res Cardiol Table 1 Edwards transcatheter heart valve registries Authors

Year of publication

Type of access

Number of patients

STS (%)

Logistic Euro Score (%)

Followup (months)

Mortality (30 days)

Mortality (1 year)

Stroke (30 days) (%)

Need for new PPM (%)

Rodes-Cabau et al. [17]

2010

TF

162

9



24

9.5

25.0

2

3.6

Thomas et al. [19, 20]

2010/2011

TF

463



14.5

12

6.3

18.9

2.4

6.7

Lefevre et al. [14] Wendler et al. [51]

2011 2012

TF TF

61 920

11.3 –

25.7 23.9

12 12

8.2 7.5

21.3 19.9

3.3 2.9

1.8 6.7

Wendler et al. [52]

2013

TF

1,685



19.8

12

4.2

15.0

3.4



Rodes-Cabau et al. [17]

2010

TA

177

10.5



12

11.3

22.0

1.7

6.2 7.3

Thomas et al. [19, 20]

2010/2011

TA

575



16.3

12

10.3

27.9

2.6

Lefevre et al. [14]

2011

TA

69

11.3

33.8

12

18.8

50.7

1.5

3.8

D’Onofrio et al. [9]

2011

TA

504

11.0

26.3

24

8.3

18.8

3.0

5.4

Wendler et al. [51]

2012

TA

1,387



27.6

12

10.9

25.8

2.5

7.1

Wendler et al. [52]

2013

TA

894



21.9

12

10.0

27.2

4.1



89.1, 80.1 and 74.2, and 72.2 and 64.7 % of the patients were still alive in the TF and TA group, respectively. Despite slightly higher 30-day mortality in the entire TA group, there was no difference between transapically and transfemorally treated patients with a logistic EuroSCORE above 20 or in patients with previous CABG. In addition, after the 3-month follow-up, the decay in the survival curve in the TA and TF cohort was similar. The SOURCE XT Registry The SOURCE was followed by SOURCE XT registry, which was conducted between July 2010 and October 2011 [52]. It contains data from 2,706 patients, that were treated through a transfemoral (62.6 %, 1,694 patients), transapical (33.5 %, 936 patients), subclavian (0.3 %) or direct aortic approach (3.6 %) with the 23, 26 or 29 mm Edwards SAPIEN XT valve, respectively. To overcome some of the limitations of SOURCE, SOURCE XT was monitored and an independent clinical committee adjudicated all events according to the VARC criteria [52]. Patients in the TA cohort were again younger (80.2 ± 6.4 vs. 81.9 ± 6.6 years in TF) had a significantly higher EuroSCORE (21.8 ± 13.8 vs. 19.9 ± 12.0 in TF) and STS Score 8.7 ± 7.2 vs. 8.4 ± 7.0 in TF). In general, the risk scores were one-third lower as compared to SOURCE in the TA and TF group, which indicates that lower risk patients were treated or the scores were overestimated in SOURCE due to a lack of monitoring. Regarding procedural complications, the occurrence of cardiac tamponade and vascular-related complications was more common in the TF group, whereas bleeding complications and new onset atrial fibrillation were more often seen in the TA group. The device success was significantly smaller and postdeployment dilatation was less often performed in the

TF as compared to the TA group. Interestingly, patients in the TA cohort were less often left behind with a moderate aortic regurgitation. The reason remains unknown, but given the fact that the 29-mm valve was only available for TA use at that time, it appears likely that some of the 26-mm valves in the TF cohort were just undersized. However, 12-months survival was 85 % in the TF group and therefore significantly better as compared to the transapically treated patients (72.8 %, p \ 0.05). In addition, the multivariate analysis showed that each approach has its own predictors of mortality with only little overlap. Therefore, TA and TF are two distinct procedures and the safety profile of each of them needs an individual assessment [52], (Table 1).

CoreValve Registries Numerous CoreValve registries have been published during the last years, which are somewhat smaller than the SOURCE registry (Table 2). The Italian Registry The Italian registry reported a procedural success of 98 % and an intraprocedural mortality of 0.9 % in a cohort of 663 patients treated with the third generation 18Fr CoreValve device in 14 centers [18, 53]. The mean age of the population was 81.0 ± 7.3 %, the logistic EuroSCORE 23.0 ± 13.7 % and patients had the typical risk profile of a transcatheter valve cohort; 21.6 % had prior myocardial infarction, 7.2 % prior stroke, 15.7 % prior CABG, 19.2 % peripheral vascular disease, 21.3 % chronic pulmonary disease and 10.9 % porcelain aorta, respectively. The approach was transfemoral in 90.3 % and trans-subclavian

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Clin Res Cardiol Table 2 Medtronic CoreValve registries Authors

Year of publication

Type of access

Number of patients

STS (%)

Logistic Euro Score (%)

Follow-up (months)

Mortality (30 days)

Mortality (1 year)

Stroke (30 days) (%)

Need for new PPM (%)

Piazza et al. [16]

2008

TF

646



23.1

1

8.0



1.9

9.3

Petronio et al. [15]

2010

TF

460



19.4

6

6.1



1.7

16.1

Tamburino et al. [18] Buellesfeld et al. [7]

2011 2011

TF TF

663 126

– –

23.0 23.0

12 24

5.4 15.2

15.0 28.2

2.5 9.6

17.4 26.2

Petronio et al. [73]

2012

SC

141



23.7

14

5.7



2.1

24.7

in the remaining 9.7 %. Implantation of the CoreValve prosthesis resulted in an instantaneous and persistent decline in aortic valve gradients paralleled by an increase in aortic valve orifice area. Valve embolization occurred in 0.6 %, conversion to open heart surgery was necessary in 0.8 % and cardiac tamponade was evident in 1.2 % of the cases; 10 % of the patients required a postdilatation of the CoreValve prosthesis, 16.6 % a new pacemaker due to heart block or persistent bradycardia. The mortality at 30 days, 6 and 12 months, was 5.4, 12.2 and 15.0 %, respectively, and therefore compares favorable to the SOURCE registry [18, 52, 53]. However, the rate of major access site complications of only 2 %, which is orders of magnitude smaller than in all other transcatheter valve studies and registries, again unmasks the problem of selfreporting of complications in the absence of independent study monitoring and of standardized end point definitions [49, 50]. The ADVANCE study The above-mentioned shortcoming is eliminated in the ADVANCE study, which aimed to evaluate outcomes following implantation of the CoreValve transcatheter aortic valve system in a fully monitored, multicenter ‘‘real world’’ patient population in highly experienced centers [54]. Highly experienced centers were chosen to eliminate the impact of the learning curve of the team on procedural outcomes. Patients at high surgical risk with severe aortic stenosis in which implantation of the CoreValve System was considered feasible by the Heart Team were included. The primary end point was a composite of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days. Primary end point-related events were fully adjudicated according to the Valve Academic Research Consortium definitions. A total of 1,015 patients (logistic EuroSCORE 19 ± 12 %, age 81 ± 6 years) were enrolled in 44 centers in 12 countries in Europe, Asia and South America between March 2010 and July 2011. Implantation of the Medtronic CoreValve System improved hemodynamics, decreased the mean and peak gradient, and

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increased the effective aortic valve orifice area. At 30 days, the rates of MACCE, total mortality, cardiovascular death and stroke were 8.0, 4.5, 3.4 and 3.0 %, respectively. Lifethreatening or disabling bleeding rate was 4.0 %. The 12-month, total mortality and stroke rates were 21.2 and 4.5 %, respectively. Therefore, ADVANCE demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in high-risk patients with severe aortic stenosis and provides insights into the TAVI data of experienced centers and operators [54].

Mixed Registries Besides the above-mentioned valve-specific reports, numerous national registries have been reported, which contain a mixed population of patients treated with the CoreValve or the Edwards SAPIEN/SAPIEN XT valve through different access routes [6, 55–58], (Table 3). In general, all of these patients were high-risk or inoperable due to comorbidities driving the surgical risk score or frailty. The UK TAVI Registry The United Kingdom transcatheter aortic valve implantation registry (UK TAVI registry) was established in 2007 and contained data form 877 TAVI procedures performed in 25 centers throughout England and Wales until December 2009 [56]. Patients had a mean age of 81.9 ± 7.1 years, a median logistic EuroSCORE of 18.5, more than two-third were implanted transfemorally and 452 patients received the Medtronic CoreValve whereas 410 patients were treated with the Edwards SAPIEN valve. The mortality at 30 days, 1 year and 2 years was 7.1, 21.4 and 26.3 % for the entire cohort, respectively. However, patients implanted transfemorally had less comorbidities and lower mortality rates at the above-mentioned time points (5.5, 18.5 and 22.5 %) as compared to patients treated through other routes (10.7, 27.7, 36.7 %, p \ 0.01). In addition, patients receiving the Medtronic CoreValve

Clin Res Cardiol Table 3 Mixed multicenter and national registries Authors

Year of publication

Type of access

Number of patients

STS (%)

Logistic Euro Score (%)

Followup (months)

Mortality (30 days)

Mortality (1 year)

Stroke (30 days) (%)

Need for new PPM (%)

Zahn et al. [55]

2011

TF, TA, SC, DA

697



20.5

1

12.4



2.8

39.3

Eltchaninoff et al. [10]

2011

TF, TA, SC

244

18.9

25.6

1

12.7



3.6

11.8

Bosmans et al. [6]

2011

TF, TA, SC

328



28.0

12

11.0

24.4

5.0

13.0

Moat et al. [56]

2011

TF, TA, SC, DA

870



18.5

12

7.1

21.4



16.3

Gilard et al. [57]

2012

TF, TA, SC

3,195

14.4

21.9

12

9.7

24.0

4.1

15.6

Chieffo et al. [82]

2013

TF

793; 453 MCV 340 ES

8.1

21.4

12

8.8

16.2

2.9

22.5

8.9

23.0

12

6.4

12.3

1.0

5.9

20.2



7.4*



1.8*

13.2*

25.9 TV



5.1 TV*



1.7 TV*

23.7 TV*

Di Mario et al. [60].

2013

TF, TA, SC, DA

4,571



Hamm et al. [59]

2013

TF, TA, SC, DA

3,876



24.5 TA

7.7 TA*

2.2 TA*

9.9 TA* TAVI Transcatheter aortic valve implantation, TF transfemoral, TA transapical, SC subclavia, TV transvascular, DA direct aortic, MCV Medtronic CoreValve, ES Edwards SAPIEN Valve, STS Society of Thoracic Surgeons, EuroSCORE European System of Cardiac Operation Risk Evaluation, PPM permanent pacemaker * In hospital

required more often a permanent pacemaker as compared to patients treated with the Edwards SAPIEN valve (24.4 vs. 7.4 %, p \ 0.001). In a multivariate analysis, presence of moderate/severe AR postprocedure, a poor baseline ejection fraction and chronic obstructive pulmonary disease were identified as predictors of 1-year mortality [56]. The Belgian Registry The Belgian registry reports data from all 15 centers performing TAVI in Belgium, of which 7 exclusively implanted the Edwards SAPIEN and 8 exclusively the Medtronic CoreValve prosthesis [6]. Up to April 2010, 328 patients were included into the registry; of those 141 received the CoreValve and 187 the Edwards SAPIEN (99 transfemoral and 88 transapical). The mean age was 83 ± 6 years and the logistic EuroSCORE 28 ± 16 %. At 1 month, mortality rates treated with the CoreValve and Edwards SAPIEN valve were 11 and 12 %, respectively. However, patients who had received the Medtronic CoreValve were more often implanted with a permanent pacemaker as compared to the Edwards cohort (22 vs. 5 %, p \ 0.001). Overall, the 1-year survival was 78 % in the CoreValve transfemoral-treated patients, 100 % in the CoreValve subclavian-treated patients (8 patients only), 82 % in the Edwards transfemoral-treated patients and 63 % in the Edwards transapical-treated patients [6].

The FRANCE 2 Registry The France 2 is the largest nationwide registry, which contains data from 3,195 TAVI patients enrolled between January 2010 and October 2011 in 34 centers [57]. The mean age was 82.7 ± 7.2 years, the logistic EuroSCORE 21.9 ± 14.3 % and the STS score 14.4 ± 11.9 %. Again, patients treated transfemorally had the lower risk profile as compared to the other access routes. The Edwards SAPIEN and the Medtronic CoreValve were used in 66.9 and 33.1 % of the cases, respectively. For the entire cohort, rates of death were 9.7 and 24.0 % at 30 days and 1 year, respectively. However, patients treated transfemorally had the lowest mortality rates with 8.5, 17.2 and 21.7 % at 1 month, 6 months and 12 months, respectively, as compared to patients treated through the subclavian artery (10.1, 23.3 and 25.1 %) or transapically (13.9, 22.4 and 32.3 %; p \ 0.001). Nevertheless, there was no difference in mortality between the Edwards SAPIEN and the CoreValve group. In a multivariate model, higher logistic EuroSCORE, NYHA class III and IV at admission, the use of transapical approach and higher amount of periprosthetic aortic regurgitation were identified as factors negatively impacting on 1-year survival [57]. In France 2, the logistic EuroSCORE is about 30 % lower as compared to PARTNER B, but the STS scores are about 50 % higher [27, 57]. This illustrated how difficult it is, to compare one

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study to another even though STS and EuroSCORE are clearly defined. In addition, it underlines that self-reporting of scores/events is potentially affected by errors and independent monitoring and adjudication of events required. However, the mortality data are robust and somewhat higher (especially for the transfemoral approach) as compared to randomized controlled trials and other registries. This discrepancy might be explain by the fact that FRANCE 2 really included all patients and reflects a real-world clinical scenario, in which some centers were still in the learning phase whereas randomized controlled trials usually include highly selected patients and other registries focused on highly experienced centers to rule out the impact of center inexperience on patient outcome. The German Transcatheter Aortic Valve Interventions Registry The German registry contained data from 697 patients with a mean age of 81.4 ± 6.3 years (44.2 % female) and a mean logistic EuroSCORE of 20.5 ± 13.3 % [55]. Of these patients, 92.4 % were treated transfemorally, 3.2 % trans-subclavian, 3.7 % transapically, 0.7 % through a transaortic approach and the Medtronic CoreValve was used in 84.4 % of all cases. Procedural complications included cardiac tamponade in 1.8 %, stroke in 2.8 % and permanent pacemaker implantation in 39.3 % at 30 days. Intrahospital mortality was 8.2 % and 30-day survival 87.6 %, respectively. Besides the lack of standardized TAVI end point definitions at the time of publication, the selection bias is the biggest shortcoming of this registry: the registry initiative, which was primarily driven by cardiologists that were in favor of a transfemoral approach, was not joined by cardiac surgeons. Therefore, the registry is lacking data from hundreds of patients treated transapically during the same period of time and hence, the outcomes of the report have to be interpreted with caution. However, especially in Germany, the implementation of this new technology increased rapidly during the last years. German Aortic Valve Registry (GARY) Based on the limitation of the above-mentioned registries, in a joint effort, the German Society of Cardiology and The German Society of Chest, Heart and Vascular Surgery founded the German aortic valve registry (GARY) [58]. GARY aims to collect and evaluate detailed information from all patients undergoing invasive treatment of acquired aortic valve disease, which includes surgical valve replacement or repair, catheter-based aortic valve implantation or stand-alone valvuloplasty. The second aim of this prospective, controlled, multicenter registry is to evaluate catheter-based procedures in comparison to surgical aortic

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valve replacement and to develop criteria for an adequate patient selection of best treatment modality. Between January 2011 and December 2011, 13,860 patients were included in 56 cardiac surgery units and 69 cardiology units in Germany [58, 59]. Of those patients, 6,523 had a surgical AVR without coronary artery bypass grafting (CABG), 3,464 surgical AVR with CABG, 2,695 transvascular TAVI and 1,181 transapical TAVI. In general, patients undergoing TAVI were significantly older and had more comorbidities. Mortality rates at 30 days and 1 year were 2.4 and 6.7 % for patients with surgical AVR, 4.5 and 11.0 % for patients with surgical AVR and CABG, 5.6 and 20.7 % for patients with transvascular TAVI and 9.0 and 28.0 % for patients with transapical TAVI, respectively. In addition, the surviving patients reported a significant improvement in clinical outcome (quality of life) and a high patient’s satisfaction with the treatment across all groups. This registry will hopefully provide us with a separate TAVI risk score aiding physicians to decide, who is going to benefit from a TAVI and who does not. The European Sentinel Registry The European sentinel registry [60] is a prospective multinational registry including 4,571 patients treated between January 2011 and May 2012 in 137 centers in 10 European countries. Patients had a mean age of 81.4 ± 7.1 years and a logistic EuroSCORE of 20.2 ± 13.3. 74.2 % of the patients were implanted transfemorally, and 1,943 patients received a Medtronic CoreValve whereas 2,604 patients were treated using Edwards SAPIEN valve. Patients treated transfemorally had a lower risk profile as compared to the other access routes. In-hospital mortality for the entire cohort was 7.4 % with no significant difference between Medtronic CoreValve (6.7 %) and Edwards SAPIEN XT (7.9 %). Patients with transfemoral approach had a significant lower inhospital mortality (5.9 %) compared to transapical (12.8 %) and other approaches (9.7 %) [60]. In a multivariate model, high age, higher logistic EuroSCORE, preprocedural mitral regurgitation (grade 2 and higher) and failure of device deployment were identified as significant predictors of mortality [60]. Numerous papers focused on subgroups of the abovementioned registries, like patients with peripheral artery occlusive disease, coronary artery disease, low-flow lowgradient aortic stenosis, postinterventional aortic regurgitation or addressed the impact of gender or center experience on TAVI outcome [61–78]. In some registries, the above-mentioned risk factors, comorbidities and procedural factors were identified as predictors of short- or longterm mortality but were not in others [61–75]. The growing experience of the operators with regard to patient selection,

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the prevention, recognition, and treatment of procedural complications together with the improvements in valve design will improve the short-term results of TAVI. There is growing evidence that the 30-day mortality after TAVI in high-risk patients can be pushed below 2.5 %, given that next-generation transcatheter valves are routinely available and the procedure is performed in a highly experienced center [74, 75]. In the USA, a randomized trial is currently evaluating the safety and efficacy of the Medtronic CoreValve prosthesis in the treatment of severely symptomatic patients with AS that have a high or extreme risk for conventional surgery (ClinicalTrials.gov Identifier: NCT01240902). It will be interesting so see, if the abovementioned expectations are met. In addition and in an attempt to expand the indications of TAVI to lower risk patients, the PARTNER IIA trial will randomize intermediate risk patients to TAVI with the SAPIEN XT or SAVR (ClinicalTrials.gov Identifier: NCT01314313) whereas the SURTAVI study will randomize 1,900 intermediate risk patients (STS score between 4 and 10) to Medtronic CoreValve implantation or SAVR. The data from these studies, especially on long-term valve durability are a prerequisite before indications can be expanded to younger, lower risk patients (ClinicalTrials.gov Identifier: NCT01586910).

Conclusion: what have we learned? Is there a decreasing mortality over time and are there fewer complications? From recent registry data, there is growing evidence that mortality and complication rates are going down, despite an unchanged risk profile of the patients. [51, 57] This effect appears to be independent of the used type of valve or access site and is seen even in already experienced centers [51, 57]. The main reason might be the growing experience of the operators with regard to patient selection, prevention, recognition and treatment of procedural complications. Thus a device-independent trend toward a lower stroke rate, lower rates of permanent pacemaker implantation and fewer bleeding as well as vascular complications became evident during the last years [51, 57, 59]. However, there are still large differences between reported events between registries [9, 52]. One reason for this finding might be the lack of independent monitoring in some registries, which leads to an underreporting of events. In addition, older registries did not report complications according to standardized end points since the VARC definitions were not available at that time [49, 50]. In all future studies and registries, the updated VARC2 definitions should be

used to ensure a standardized comparison between the different registries and studies [50]. Why do the risk scores decrease over time? Due to the growing TAVI experience, which is accompanied by a decrease in short-term mortality as compared to the older registries, there is an expansion of the methodology to younger and lower risk patients, although there are no data available from randomized controlled trials justifying an expansion of indications. [51, 52, 60] In addition, there are also younger, informed patients who refuse surgery and explicitly ask for TAVI. However, it is the responsibility of the heart team to critically evaluate the patients and convince them to undergo conventional surgery, if this is the recommended treatment according to the current guidelines. Aortic regurgitation: an important risk factor? Moderate and severe intraprosthetic or paraprosthetic aortic regurgitation (AR) after TAVI has been identified as an independent predictor of an inferior outcome and higher all-cause and cardiovascular mortality [79]. In the French registry at 30 days, intraprosthetic regurgitation (grade 1/grade 2/grade 3) occurred in 7.8/1.2/0.2 % of the patients, periprosthetic regurgitation in 47.4/16.3/0.8 % with no significant difference between the access sites or between the Edwards SAPIEN and Medtronic CoreValve prosthesis [57]. In multivariate analysis, AR grade 2 or higher compared to grade 1 or lower was associated with a significant higher mortality [57]. A strong asymmetric calcification, an underestimated annulus diameter and thus an implantation of an undersized valve were identified as independent risk factors for the development of AR [45, 79]. Next-generation devices are required to lower the rate of AR. The LotusTM valve seems to be promising in this regard, since very low rates of paraprosthetic AR at 30-day follow-up have been described in the REPRISE II trial [80]. Only 1 patient out of the 60 patients had moderate AR, more than 80 % of the patients had no or only trace AR [80]. However, if this has a favorable effect on intermediate and long-term outcome has to be addressed in future studies. Which issues should be addressed in future? It is still unknown, of whether TAVI is an alternative to conventional surgery in younger patients with a lower number of risk factors. The SURTAVI trial is designed to address this issue (ClinicalTrials.gov Identifier: NCT01586910). Moreover, further studies are required to evaluate the next-generation devices in a broader patient

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population to understand, of whether the theoretical benefits of the improved valve designs translate into fewer complications and a better long-term survival. The new registries e.g., the STS-ACC registry [81] will provide a first glimpse into the future. Acknowledgments Dr. Linke is a consultant to Medtronic and St. Jude Medical. He received speaker honoraria from Edwards, Medtronic and St. Jude Medical and is a proctor for Medtronic, Edwards and St. Jude Medical. Prof. Schuler and Dr. Haussig report no conflict of interest.

13.

14.

15.

References 16. 1. Woitek FJ, linke A (2012) Aortic valve stenosis: matching the approach to the patient. Dtsch Med Wochenschr 137:648–651. doi:10.1055/s-0031-1298990 2. Ross J, Braunwald E (1968) Aortic stenosis. Circulation 38:61–67 3. Iung B, Cachier A, Baron G et al (2005) Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 26:2714–2720. doi:10.1093/eur heartj/ehi471 4. Bach DS, Siao D, Girard SE et al (2009) Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes 2:533–539. doi:10.1161/CIRCOUTCOMES.109.848259 5. Cribier A, Eltchaninoff H, Bash A et al (2002) Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 106:3006–3008 6. Bosmans JM, Kefer J, De Bruyne B et al (2011) Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: results of the Belgian national registry. Interact Cardiovasc Thorac Surg 12:762–767. doi:10.1510/icvts.2010.253773 7. Buellesfeld L, Gerckens U, Schuler G et al (2011) 2-year followup of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis. J Am Coll Cardiol 57:1650–1657. doi:10.1016/j.jacc.2010.11.044 8. Cribier A, Eltchaninoff H, Tron C et al (2006) Treatment of calcific aortic stenosis with the percutaneous heart valve: midterm follow-up from the initial feasibility studies: the French experience. J Am Coll Cardiol 47:1214–1223. doi:10.1016/j.jacc. 2006.01.049 9. D’Onofrio A, Rubino P, Fusari M et al (2011) Clinical and hemodynamic outcomes of ‘‘all-comers’’ undergoing transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). J Thorac Cardiovasc Surg 142:768–775. doi:10.1016/j.jtcvs.2011.06.026 10. Eltchaninoff H, Prat A, Gilard M et al (2011) Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J 32:191–197. doi:10.1093/eurheartj/ehq261 11. Grube E, Laborde JC, Gerckens U et al (2006) Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-inman study. Circulation 114:1616–1624. doi:10.1161/CIRCULA TIONAHA.106.639450 12. Grube E, Schuler G, Buellesfeld L et al (2007) Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-

123

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

expanding CoreValve prosthesis: device success and 30-day clinical outcome. J Am Coll Cardiol 50:69–76. doi:10.1016/j. jacc.2007.04.047 Himbert D, Descoutures F, Al-Attar N et al (2009) Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk patients with aortic stenosis. J Am Coll Cardiol 54:303–311. doi:10.1016/j.jacc.2009.04.032 Lefevre T, Kappetein AP, Wolner E et al (2011) One year followup of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J 32:148–157. doi:10.1093/eurheartj/ ehq427 Petronio AS, De Carlo M, Bedogni F et al (2010) Safety and efficacy of the subclavian approach for transcatheter aortic valve implantation with the CoreValve revalving system. Circ Cardiovasc Interv 3:359–366. doi:10.1161/CIRCINTERVENTIONS. 109.930453 Piazza N, Grube E, Gerckens U et al (2008) Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. EuroIntervention 4:242–249 Rode´s-Cabau J, Webb JG, Cheung A et al (2010) Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol 55:1080–1090. doi:10.1016/j.jacc.2009.12.014 Tamburino C, Capodanno D, Ramondo A et al (2011) Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 123:299–308. doi:10.1161/CIRCULATIONAHA. 110.946533 Thomas M, Schymik G, Walther T et al (2011) One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 124:425–433. doi:10.1161/CIRCULA TIONAHA.110.001545 Thomas M, Schymik G, Walther T et al (2010) Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 122:62–69. doi:10.1161/CIRCULATIONAHA.109.907402 Webb JG, Chandavimol M, Thompson CR et al (2006) Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation 113:842–850. doi:10.1161/CIRCULATIO NAHA.105.582882 Svensson LG, Dewey T, Kapadia S et al (2008) United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex. Ann Thorac Surg 86:46–54. doi:10. 1016/j.athoracsur.2008.04.049 discussion 54–5 Walther T, Kasimir M-T, Doss M et al (2011) One-year interim follow-up results of the TRAVERCE trial: the initial feasibility study for trans-apical aortic-valve implantation. Eur J Cardiothorac Surg 39:532–537. doi:10.1016/j.ejcts.2010.06.002 Beller CJ, Schmack B, Seppelt P et al (2013) The groin first approach for transcatheter aortic valve implantation: are we pushing the limits for transapical implantation? Clin Res Cardiol 102:111–117. doi:10.1007/s00392-012-0502-9 Blumenstein J, Van Linden A, Kim WK et al (2013) Early SAPIEN transcatheter heart valve dysfunction due to tissue ingrowth in an octogenarian. Clin Res Cardiol 102:237–240. doi:10.1007/s00392-012-0518-1 Blumenstein J, Van Linden A, Kempfert J et al (2012) Retrograde, transsubclavian implantation of a SAPIEN XTTM aortic valve prosthesis with the Edwards NovaFlex?TM system. Clin Res Cardiol 101:773–775. doi:10.1007/s00392-012-0460-2

Clin Res Cardiol 27. Leon MB, Smith CR, Mack M et al (2010) Transcatheter aorticvalve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363:1597–1607. doi:10.1056/ NEJMoa1008232 28. Smith CR, Leon MB, Mack MJ et al (2011) Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364:2187–2198. doi:10.1056/NEJMoa1103510 29. Chorianopoulos E, Krumsdorf U, Pleger ST et al (2012) Incidence of late occurring bradyarrhythmias after TAVI with the self-expanding CoreValveÒ aortic bioprosthesis. Clin Res Cardiol 101:349–355. doi:10.1007/s00392-011-0398-9 30. Chorianopoulos E, Krumsdorf U, Geis N et al (2014) Preserved prognostic value of preinterventional troponin T levels despite successful TAVI in patients with severe aortic stenosis. Clin Res Cardiol 103:65–72. doi:10.1007/s00392-013-0624-8 31. Conradi L, Seiffert M, Franzen O et al (2011) First experience with transcatheter aortic valve implantation and concomitant percutaneous coronary intervention. Clin Res Cardiol 100:311–316. doi:10.1007/s00392-010-0243-6 32. Dimitriadis Z, Wiemer M, Scholtz W et al (2013) Sleep-disordered breathing in patients undergoing transfemoral aortic valve implantation for severe aortic stenosis. Clin Res Cardiol 102:895–903. doi:10.1007/s00392-013-0603-0 33. Gotzmann M, Mu¨gge A (2011) Fatal prosthetic valve endocarditis of the CoreValve ReValving System. Clin Res Cardiol 100:715–717. doi:10.1007/s00392-011-0315-2 34. Greif M, Lange P, Mair H et al (2012) Transcatheter Edwards Sapien XT valve in valve implantation in degenerated aortic bioprostheses via transfemoral access. Clin Res Cardiol 101:993–1001. doi:10.1007/s00392-012-0488-3 35. Koene BM, Soliman Hamad MA, Bouma W et al (2013) Can postoperative mean transprosthetic pressure gradient predict survival after aortic valve replacement? Clin Res Cardiol. doi:10. 1007/s00392-013-0629-3 36. Motloch LJ, Rottlaender D, Reda S et al (2012) Local versus general anesthesia for transfemoral aortic valve implantation. Clin Res Cardiol 101:45–53. doi:10.1007/s00392-011-0362-8 37. Muensterer A, Mazzitelli D, Ruge H et al (2013) Safety and efficacy of the subclavian access route for TAVI in cases of missing transfemoral access. Clin Res Cardiol 102:627–636. doi:10.1007/s00392-013-0575-0 38. Vavuranakis M, Vrachatis DA, Boudoulas H et al (2012) Effect of transcatheter aortic valve implantation on the ascending aorta’s elasticity. Clin Res Cardiol 101:895–899. doi:10.1007/s00392012-0473-x 39. Zahn R, Schiele R, Zeymer U et al (2013) Occlusion of the left main stem: a rare, but life-threatening complication of transcatheter aortic valve implantation with the Medtronic CoreValveTM prosthesis. Clin Res Cardiol 102:323–326. doi:10.1007/ s00392-013-0538-5 40. Zuern CS, Eick C, Rizas K et al (2012) Prognostic value of mildto-moderate pulmonary hypertension in patients with severe aortic valve stenosis undergoing aortic valve replacement. Clin Res Cardiol 101:81–88. doi:10.1007/s00392-011-0367-3 41. Ewert P, Horlick E, Berger F (2011) First implantation of the CEmarked transcatheter Sapien pulmonic valve in Europe. Clin Res Cardiol 100:85–87. doi:10.1007/s00392-010-0214-y 42. Haas NA, Moysich A, Neudorf U et al (2013) Percutaneous implantation of the Edwards SAPIENTM pulmonic valve: initial results in the first 22 patients. Clin Res Cardiol 102:119–128. doi:10.1007/s00392-012-0503-8 43. Kempfert J, Mo¨llmann H, Walther T (2012) Symetis ACURATE TA valve. EuroIntervention 8(Suppl Q):Q102–Q109. doi:10. 4244/EIJV8SQA19 44. Treede H, Rastan A, Ferrari M et al (2012) JenaValve. EuroIntervention 8(Suppl Q):Q88–Q93. doi:10.4244/EIJV8SQA16

45. Falk V, Walther T, Schwammenthal E et al (2011) Transapical aortic valve implantation with a self-expanding anatomically oriented valve. Eur Heart J 32:878–887. doi:10.1093/eurheartj/ ehq445 46. Manoharan G, Spence MS, Rode´s-Cabau J, Webb JG (2012) St Jude Medical Portico valve. EuroIntervention 8(Suppl Q):Q97– Q101. doi:10.4244/EIJV8SQA18 47. Bijuklic K, Tu¨bler T, Low RI et al (2012) Direct Flow Medical valve. EuroIntervention 8(Suppl Q):Q75–Q80. doi:10.4244/ EIJV8SQA13 48. Kodali SK, O’Neill WW, Moses JW et al (2011) Early and late (one year) outcomes following transcatheter aortic valve implantation in patients with severe aortic stenosis (from the United States REVIVAL trial). Am J Cardiol 107:1058–1064. doi:10.1016/j.amjcard.2010.11.034 49. Leon MB, Piazza N, Nikolsky E et al (2011) Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol 57(3):253–269 50. Kappetein AP, Head SJ, Ge´ne´reux P et al (2012) Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. JAC 60:1438–1454. doi:10.1016/j.jacc.2012. 09.001 51. Wendler O, Walther T, Schroefel H et al (2011) The SOURCE Registry: what is the learning curve in trans-apical aortic valve implantation? Eur J Cardio-Thoracic Surg 39:853–859. doi:10. 1016/j.ejcts.2010.11.018 discussion 859–860 52. Wendler O Transapical versus transfemoral TAVI: real-world data (SOURCE XT registry)-2012-Lectures-PCRonline. In: pcronline.com. http://www.pcronline.com/Lectures/2012/Transa pical-versus-transfemoral-TAVI-real-world-data-SOURCE-XTregistry. Accessed 15 Jan 2014 53. Ussia GP, Barbanti M, Petronio AS et al (2012) Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis. Eur Heart J 33:969–976. doi:10.1093/eur heartj/ehr491 54. Linke A, Gerckens U, Wenaweser P, et. al. (2012) Treatment of High Risk Aortic Stenosis Patients with transcatheter Medtronic CoreValve Implantation: results from the International Multicenter ADVANCE Study. J Am Coll Cardiol 59(1s1): E3–E8 doi: 10.1016/S0735-1097(12)6009-6 55. Zahn R, Gerckens U, Grube E et al (2011) Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J 32:198–204. doi:10.1093/eurheartj/ehq339 56. Moat NE, Ludman P, de Belder MA et al (2011) Long-term outcomes after transcatheter aortic valve implantation in highrisk patients with severe aortic stenosis: the UK TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. J Am Coll Cardiol 58:2130–2138. doi:10.1016/j.jacc.2011.08. 050 57. Gilard M, Eltchaninoff H, Iung B et al (2012) Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 366:1705–1715. doi:10.1056/NEJMoa1114705 58. Beckmann A, Hamm C, Figulla HR et al (2012) The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis. Thorac Cardiovasc Surg 60:319–325. doi:10.1055/s-00321323155 59. Hamm CW, Mo¨llmann H, Holzhey D et al (2013) The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J. doi:10.1093/eurheartj/eht381 60. Di Mario C, Eltchaninoff H, Moat N et al (2013) The 2011–12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients. EuroIntervention 8:1362–1371. doi:10.4244/EIJV8I12A209

123

Clin Res Cardiol 61. Zahn R, Gerckens U, Linke A et al (2013) Predictors of one-year mortality after transcatheter aortic valve implantation for severe symptomatic aortic stenosis. Am J Cardiol 112:272–279. doi:10. 1016/j.amjcard.2013.03.024 62. Ledwoch J, Franke J, Gerckens U et al (2013) Incidence and predictors of permanent pacemaker implantation following transcatheter aortic valve implantation: analysis from the German transcatheter aortic valve interventions registry. Catheter Cardiovasc Interv 82:E569–E577. doi:10.1002/ccd.24915 63. Zahn R, Schiele R, Gerckens U et al (2013) Transcatheter aortic valve implantation in patients with ‘‘porcelain’’ aorta (from a Multicenter Real World Registry). Am J Cardiol 111:602–608. doi:10.1016/j.amjcard.2012.11.004 64. Buellesfeld L, Gerckens U, Erbel R et al (2012) Age-stratified baseline and outcome characteristics of patients undergoing transcatheter aortic valve implantation: results from the German multicenter registry. J Invasive Cardiol 24:531–536 65. Sinning J-M, Horack M, Grube E et al (2012) The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: results from the German Transcatheter Aortic Valve Interventions Registry. Am Heart J 164(102–10):e1. doi:10.1016/j.ahj.2012.04.016 66. Lauten A, Zahn R, Horack M et al (2012) Transcatheter aortic valve implantation in patients with low-flow, low-gradient aortic stenosis. JACC Cardiovasc Interv 5:552–559. doi:10.1016/j.jcin. 2012.04.001 67. Fiorina C, Barbanti M, De Carlo M et al (2013) One year clinical outcomes in patients with severe aortic stenosis and left ventricular systolic dysfunction undergoing transcatheteter aortic valve implantation: results from the Italian CoreValve Registry. Int J Cardiol 168:4877–4879. doi:10.1016/j.ijcard.2013.07.049 68. D’Ascenzo F, Gonella A, Moretti C et al (2013) Gender differences in patients undergoing TAVI: a multicentre study. EuroIntervention 9:367–372. doi:10.4244/EIJV9I3A59 69. Ussia GP, Barbanti M, Colombo A et al (2013) Impact of coronary artery disease in elderly patients undergoing transcatheter aortic valve implantation: insight from the Italian CoreValve Registry. Int J Cardiol 167:943–950. doi:10.1016/j.ijcard.2012. 03.089 70. Tamburino C, Barbanti M, Capodanno D et al (2012) Comparison of complications and outcomes to one year of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis. Am J Cardiol 109:1487–1493. doi:10.1016/j.amjcard.2012.01.364 71. Khawaja MZ, Rajani R, Cook A et al (2011) Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK

123

72.

73.

74.

75.

76.

77.

78.

79.

80. 81.

82.

CoreValve Collaborative). Circulation 123:951–960. doi:10. 1161/CIRCULATIONAHA.109.927152 Roy DA, Schaefer U, Guetta V et al (2013) Transcatheter aortic valve implantation for pure severe native aortic valve regurgitation. J Am Coll Cardiol 61:1577–1584. doi:10.1016/j.jacc.2013. 01.018 Petronio AS, De Carlo M, Bedogni F et al (2012) 2-year results of CoreValve implantation through the subclavian access: a propensity-matched comparison with the femoral access. J Am Coll Cardiol 60:502–507. doi:10.1016/j.jacc.2012.04.014 van Mieghem NM, Chieffo A, Dumonteil N et al (2013) Trends in outcome after transfemoral transcatheter aortic valve implantation. Am Heart J 165:183–192. doi:10.1016/j.ahj.2012.11.002 Lange R, Bleiziffer S, Mazzitelli D et al (2012) Improvements in transcatheter aortic valve implantation outcomes in lower surgical risk patients: a glimpse into the future. J Am Coll Cardiol 59:280–287. doi:10.1016/j.jacc.2011.10.868 Abdel-Wahab M, Zahn R, Horack M et al (2012) Transcatheter aortic valve implantation in patients with and without concomitant coronary artery disease: comparison of characteristics and early outcome in the German multicenter TAVI registry. Clin Res Cardiol 101:973–981. doi:10.1007/s00392-012-0486-5 Abdel-Wahab M, Mostafa AE, Richardt G (2012) A case of rotational atherectomy after implantation of the Medtronic CoreValve bioprosthesis. Clin Res Cardiol 101:595–597. doi:10. 1007/s00392-012-0443-3 Akin I, Kische S, Schneider H et al (2012) Surface and intracardiac ECG for discriminating conduction disorders after CoreValve implantation. Clin Res Cardiol 101:357–364. doi:10. 1007/s00392-011-0400-6 Abdel-Wahab M, Zahn R, Horack M et al (2011) Aortic regurgitation after transcatheter aortic valve implantation: incidence and early outcome. Results from the German transcatheter aortic valve interventions registry. Heart 97:899–906. doi:10.1136/hrt. 2010.217158 Tofield A (2013) The Lotus valve for transcatheter aortic valve implantation. Eur Heart J 34:2335 Carroll JD, Edwards FH, Marinac-Dabic D et al (2013) The STSACC transcatheter valve therapy national registry. JACC 62:1026–1034. doi:10.1016/j.jacc.2013.03.060 Chieffo A, Buchanan GL, van Mieghem NM et al (2013) Transcatheter aortic valve implantation with the Edwards SAPIEN versus the Medtronic CoreValve Revalving system devices: a multicenter collaborative study: the PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration). J Am Coll Cardiol 61:830–836. doi:10.1016/j.jacc.2012.11.050

Worldwide TAVI registries: what have we learned?

With a rapidly aging society, the number of patients with cardiovascular disease-in particular aortic stenosis-is progressively increasing. Although c...
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