Registries Show Strides for Transcatheter Valve Treatments in Europe

MUNICH, Germany—Two large registries on valvular disease—aortic and mitral—show good results with percutaneous treatment in Europe. The findings were presented August 27, 2012, at the European Society of Cardiology Congress.

The German TAVR Experience

Christian W. Hamm, MD, PhD, of Kerckhoff Heart and Thorax Center (Bad Nauheim, Germany), shared the early data from the German Aortic Valve RegistrY (GARY), which began enrolling patients in July 2010 and expects to include a total of 80,000 patients treated at 92  centers through 2015. The registry includes patients treated with both transcatheter aortic valve replacement (TAVR) and surgery.

Current results are derived from a cohort of nearly 14,000 patients treated in 2011 at 53 centers. TAVR patients tended to be older, with 85% over the age of 75 years; in comparison, 44.9% of those who had valve surgery in conjunction with CABG and 33.3% of those treated with valve surgery alone were elderly. In addition, women made up a higher proportion of TAVR patients. Logistic EuroSCORE and baseline prevalence of New York Heart Association class III/IV also were higher in TAVR vs. surgically treated patients.

Within the TAVR group, 59.8% of the transvascular cohort received CoreValve devices (Medtronic, Minneapolis, MN) and 38.2% received Sapien devices (Edwards Lifesciences, Irvine, CA), while 2.0% received other devices. The distribution in the transapical cohort was 87.5% Sapien, 4.5% JenaValve (JenaValve Technology, Munich, Germany), 4.5% Symetis (Symetis, Ecublens, Switzerland), and 3.6% other.

In-hospital mortality, cerebrovascular events, vascular complications, and need for new pacemaker all were higher after percutaneous treatment, though rates were consistent with earlier observations (table 1).

Table 1. In-Hospital Outcomes

 

 

Valve Surgery Alone
(n = 6,517)

Valve Surgery + CABG
(n = 3,458)

Transvascular TAVR
(n = 2,689)

Transapical TAVR
(n = 1,177)

Mortality

2.1%

4.5%

5.1%

7.7%

Cerebrovascular Events

2.2%

3.6%

3.7%

3.5%

Vascular Complications

1.0%

1.6%

11.9%

2.5%

New Pacemaker

4.6%

3.9%

23.7%

9.9%


For both treatments, “you may appreciate that there is a major difference in that the observed risk for mortality is much lower than estimated by the logistic EuroSCORE, [suggesting it] is not very suitable in this scenario.” Instead, he noted, the German Aortic Valve Disease score known as AKL appears to be a better match.

Among TAVR patients, risk-adjusted in-hospital mortality was higher with transapical access, particularly in those younger than 75.

Congratulating the researchers for conducting the first national registry on both surgical and transcatheter aortic valve procedures, Olaf Wendler, MD, PhD, of King’s College Hospital (London, United Kingdom), questioned GARY’s completeness. Bias may arise from the fact that not all German centers are not participating and that, even at participating centers, not every operator may take part.  Moreover, he observed, the ESC presentation lacks definitions for certain baseline characteristics and outcomes.

In addition, Dr. Wendler said it was “slightly surprising” to see more Sapien than CoreValve devices implanted, given that the market share in Germany is the other way around. “Therefore, the question again is whether there is a selection criteria for centers included in this registry,” he noted, stressing that device type can affect outcomes.

European Perspective on Mitral Valve Repair

During the same session, Wolfgang Schillinger, MD, of Universitatsmedizin Gottingen (Gottingen, Germany), presented 1-year outcomes for 567 patients from phase I of ACCESS-EUROPE, a postmarket study of the MitraClip system (Abbott Vascular, Santa Clara, CA) for treating mitral regurgitation. Enrollment took place at 14 European sites from October 2008 to April 2011. MitraClip gained CE-mark approval in Europe in 2008 but is still an investigational device in the United States.

At baseline, the European registry patients, who had a mean logistic EuroSCORE of 23 ± 18, were older and had more comorbidities than patients who had taken part in the EVEREST II randomized controlled trial of surgical vs. percutaneous repair, or in its high surgical risk cohort.

Most patients in ACCESS-EUROPE received either 1 clip (60.1%) or 2 clips (36.7%), with a successful implantation rate of 99.6%. Median length of stay was 6 days in the hospital and 1 day in the intensive care unit. The majority of patients (79.8%) were discharged home with the remainder discharged to a skilled nursing facility or hospital (17.1%) or a nursing home (1.4%). Two percent died before discharge.

Outcomes were worse in patients with higher baseline risk, a difference “much more likely to be related to comorbidities than to the procedure itself,” Dr. Schillinger said, reporting 1-year results (table 1).

Table 1. Site-Reported Outcomes at 1 Year

 

Overall
(n = 567)

Logistic EuroSCORE 20%
(n = 253)

Logistic EuroSCORE < 20%
(n = 324)

Death

17.3%

22.9%

12.7%

Stroke

1.1%

1.6%

0.6%

MI

1.4%

2.0%

1.0%

Renal Failure

8.6%

11.5%

6.4%

Respiratory Failure

0.9%

1.6%

0.3%

Need for Resuscitation

2.1%

3.6%

1.0%

Cardiac Tamponade

1.2%

1.6%

1.0%

Bleeding Complications

4.8%

6.3%

3.5%


Single-leaf device attachment was observed in 4.8% of MitraClip patients. Within 1 year, 6.4% of patients required mitral valve surgery and 3.4% underwent an additional MitraClip procedure.

In matched pair analyses, MR grade decreased from baseline to 1 year (P < 0.0001), with 79% of patients below grade 2. Improvement was also seen in NHYA class (P < 0.0001), with 72% of patients in class I/II by 1 year. Quality of life scores and 6-minute walk test results also were better after treatment (P < 0.0001 for both).

“The MitraClip procedure provides meaningful clinical benefits to patients with significant MR in a real-world setting consistent with results in controlled clinical trials,” Dr. Schillinger concluded, noting that more than 6,000 patients have been treated worldwide, most of whom were poor surgical candidates. “The MitraClip therapy therefore provides a treatment option for a patient population with an important unmet clinical need.”

Commenting after the presentation, Simon Ray, MD, of Manchester Academic Health Sciences Center (Manchester, United Kingdom), was similarly positive. “What has been so elegantly demonstrated . . . is that ACCESS-EUROPE adds important confirmatory data to existing studies,” he noted. “Overall, this study demonstrates that in expert hands, MitraClip implant[ation] is feasible and safe, with acceptable procedural risk in complex, comorbid patients.”

However, further study is needed to look at this high-risk population that diverges from what was seen in EVEREST II, he said. Considerable heterogeneity exists among centers in real-world practice, he said, adding that with 25 to 35 percent of patients deriving no symptomatic benefit, more needs to be learned about patient selection.

 

 


Sources:

1. Hamm CW. GARY: German Aortic Valve RegistrY: In-hospital outcome. Presented at: European Society of Cardiology Congress; August 27, 2012; Munich, Germany

2. Schillinger W. ACCESS-EUROPE: An observational study of the MitraClip system in Europe.

Presented at: European Society of Cardiology Congress; August 27, 2012; Munich, Germany

 

 

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Disclosures
  • The GARY registry is sponsored by Edwards Lifesciences, Jena Valve, Medtronic, Sorin, St. Jude Medical, and Symetis.
  • Dr. Hamm reports receiving honoraria for lectures from Edwards Lifesciences and Medtronic and for advisory board activities from Medtronic and participating in trials sponsored by Edwards Lifesciences, Jena Valve, Medtronic, and Symetis.
  • Dr. Wendler reports holding research contracts with Edwards Lifesciences and consulting for Edwards Lifesciences, JenaValve, Medtronic, and St. Jude Medical.
  • The ACCESS-EUROPE study is sponsored by Abbott Vascular.
  • Dr. Schillinger reports receiving consulting fees and honoraria from Abbott Vascular, Abiomed, AstraZeneca, Edwards Lifesciences, Servier, and St. Jude Medical.
  • Dr. Ray reports no conflicts of interest.

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