Real-World TAVI Outcomes Spot On With Clinical Trial Results

MUNICH – In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY during a hotline session at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said. Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

Patrice Wendling/IMNG Medical Media

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve. Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH – In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY during a hotline session at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said. Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

Patrice Wendling/IMNG Medical Media

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve. Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH – In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY during a hotline session at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said. Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

Patrice Wendling/IMNG Medical Media

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve. Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.