Thoracic Surgery News (Archived)

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) 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 the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received 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.

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) 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 the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received 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.

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) 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 the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received 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.

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) 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 the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received 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.

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) 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 the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received 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.

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) 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 the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received 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.

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.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

One day after President Obama's reelection, we caught up with Dr. Elliott Antman, American Heart Association's 2012 Program Chair, for comments on how the results of the election could impact physicians' practices and patient care.

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, reported on 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of unrealted causes, she said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008;1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi reported no conflicts.☐

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, reported on 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of unrealted causes, she said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008;1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi reported no conflicts.☐

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, reported on 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of unrealted causes, she said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008;1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi reported no conflicts.☐

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, reported on 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of unrealted causes, she said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008;1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi reported no conflicts.☐

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, reported on 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of unrealted causes, she said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008;1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi reported no conflicts.☐

SAN FRANCISCO – Successful outcomes in 74 of 79 patients who underwent robotic-assisted thymectomy suggest that the technology is safe and feasible, results of a multicenter European study demonstrate.

Dr. Franca Melfi, of the University of Pisa in Italy, reported on 79 patients with early thymoma who were surgically treated at multiple centers in Europe between 2002 and 2011. More than half, 45 patients, had myasthenia gravis. At last follow-up, 74 patients were still alive and free from recurrence. One patient died of a diffuse intrathoracic recurrence and the others died of unrealted causes, she said at the annual meeting of the American Association for Thoracic Surgery.

Improved depth perception and precise movements facilitated by articulated instruments are among the benefits of the robotic approach. The robot facilitates safe access to the thymus in the upper mediastinal area where the space is small and there are numerous vessels. This approach also allows a prolonged thymectomy when removal of all the fat is required, she explained.

The 608 reported robotic-assisted thymectomies worldwide come from 43 papers published since 2003, but most feature a small number of patients and/or a short follow-up, Dr. Melfi said. One of the few larger studies of robotic-assisted thymectomy included 106 patients with myasthenia gravis (Ann. N.Y. Acad. Sci. 2008;1132:329-35). Researchers in this prospective study reported a mean operative time of 186 minutes, a 1% conversion rate, and a 30-day mortality of 0%. They had a low overall postoperative morbidity rate (2 of 95 patients): one instance of bleeding and one nerve injury.

A greater than 40% complete and stable remission rate for myasthenia gravis was "a real interesting result," Dr. Melfi said, noting that mean follow-up was 20 months. Most participants reported improved quality of life, she added.

Additional clinical experience and refinements are warranted, Dr. Melfi said, acknowledging the need for prospective, randomized trials.

Dr. Melfi reported no conflicts.☐