Transcatheter mitral valve redos work, except in highest-risk patients

TORONTO – Transcatheter mitral valve-in-valve/valve-in-ring implantation is an effective option in most patients with degenerative mitral valves after surgical intervention, according to Dr. Danny Dvir.

In the highest-risk patients (STS scores greater than 20%), however, mortality after this percutaneous technique approached 50% at 1 year, Dr. Dvir reported at the American Association for Thoracic Surgery annual meeting.

"Most of these procedures were clinically effective, with 1-year results that are comparable to native aortic valve transcatheter implantation," said Dr. Dvir of St. Paul’s Hospital, Vancouver, B.C.

"However, we saw safety and efficacy concerns that included relatively high in-hospital mortality, device malposition, sporadic cases with elevated LVOT [left ventricular outflow tract] gradient, and elevated postprocedural gradients in procedures performed inside small surgical valves."

Dr. Joseph E. Bavaria, professor of surgery and director of the thoracic aortic surgery program at the University of Pennsylvania Health System, Philadelphia, the scheduled discussant of the abstract, asked, referring to the STS score greater than 20% group: "Is this really a cohort C or futile situation, where [the intervention] is probably not better than medical management?"

Transcatheter VIV/VIR

The majority of prosthetic heart valves are tissue valves that tend to degenerate and eventually fail over time. Surgical replacement of these valves is associated with significant risks.

Transcatheter valve-in-valve/valve-in-ring (VIV/VIR) implantation within a failed bioprosthesis performed in the mitral position has been reported in only small case series, with the safety and efficacy of the technique being largely unknown. The Global Valve-in-Valve Registry, with 765 patients from 73 centers worldwide, was designed to track the efficacy and safety of this nonsurgical redo in either the aortic or mitral valve position. The registry included 190 patients from 23 centers who underwent percutaneous mitral valve procedures (VIV in 157 patients and VIR in 33).

The mechanism of failure was regurgitation in 37%, stenosis in 25%, and a combination of the two in 38%. Patients were a median of 9 years past their last cardiac surgery and were deemed at high risk, with a mean STS score of 14.4. The mean age was 73.6 years, and 65.2% were female. The median length of hospital stay was 8 days.

A SAPIEN or SAPIEN XT device was used in the majority of cases (93.7%), mostly deployed via transapical access (84.7%).

During the procedure, initial device malpositioning occurred in 5.3% of cases, with a second device implanted in 4.3%. Postimplantation valvuloplasty was utilized in 8%.

"We saw a high rate of malpositioning," Dr. Dvir said. "In some of the cases, this led to a decision to leave the malpositioned device in the left atrium and implant a second device."

The incidence of all-cause death at 30 days was 8.9%, with cardiovascular death seen in 6.8% and major stroke in 2.2%. Importantly, 85.8% of patients were in NYHA function class I or II at 30 days, Dr. Dvir said.

"We were very happy to see this," he commented. "If you survive the valve-in-valve or valve-in-ring procedure, you will most likely have a good functional class.

Overall, the Kaplan-Meier mortality rate was 22.3% at 1 year. When stratified according to STS score, however, mortality in the group of patients with an STS score greater than 20% was 45.6%, falling to 23.2% for an STS score of 10%-20% and 12.9% for an STS score less than 10%. Predictors of 1-year mortality included STS score and renal failure.

"In these patients with STS greater than 20%, there is really a big problem. We need to understand which patients should not undergo a procedure, and maybe should be treated with an alternative approach," Dr. Dvir said. He noted that 28% of cases in the registry were in this highest-risk category.

"An 8.9% mortality at 1 year is not so bad in a group with a mean STS score of 14.1," noted Dr. Bavaria. "[But] this is not really a benign procedure as the length of stay was over 8 days."

Surgical valve sizing gone wrong?

After the VIV/VIR procedure, the mean mitral valve area was 2.1 ± 0.7 cm², with a mean residual gradient of 6.2 mm Hg. Significant mitral regurgitation was noted in 4.2% of patients, and a left ventricular outflow tract mean gradient greater than 20 mm Hg was noted in only 2.1% of cases.

"We saw a trend for elevated gradients especially when we were treating small valves with a valve-in-valve approach," Dr. Dvir said.

Indeed, in the patients with smaller surgical valve label size, one-third had postprocedural mean gradients greater than 10 mm Hg. The rates of mean gradient greater than 10 mm Hg dropped to 7.4% and 5.3% with progressively larger surgical valve label sizes.

"I am very worried about the cardiac surgery and interventional cardiology decision-making process, as over 60% of valve-in-ring cases were 26-mm and 28-mm rings and over 56% of valve-in-valve cases were less than or equal to 27-mm prosthetic valves," said Dr. Bavaria. "There will obviously be significant mitral gradients in these cases, as this study showed. Is this simply a lack of knowledge in the operators, should these small valve-in-valve cases be done, or is this a limit of this technology?"

"I think this issue of residual gradients will haunt valve in valve for many years to come," said Dr. Dvir. "However, we know from the aortic arena, that even if you have a high residual gradient, the results at 1 year are not different than the other groups. So, it doesn’t affect 1-year outcomes, although I predict that it will affect the durability of the device and the long-term outcome."

TORONTO – Transcatheter mitral valve-in-valve/valve-in-ring implantation is an effective option in most patients with degenerative mitral valves after surgical intervention, according to Dr. Danny Dvir.

In the highest-risk patients (STS scores greater than 20%), however, mortality after this percutaneous technique approached 50% at 1 year, Dr. Dvir reported at the American Association for Thoracic Surgery annual meeting.

"Most of these procedures were clinically effective, with 1-year results that are comparable to native aortic valve transcatheter implantation," said Dr. Dvir of St. Paul’s Hospital, Vancouver, B.C.

"However, we saw safety and efficacy concerns that included relatively high in-hospital mortality, device malposition, sporadic cases with elevated LVOT [left ventricular outflow tract] gradient, and elevated postprocedural gradients in procedures performed inside small surgical valves."

Dr. Joseph E. Bavaria, professor of surgery and director of the thoracic aortic surgery program at the University of Pennsylvania Health System, Philadelphia, the scheduled discussant of the abstract, asked, referring to the STS score greater than 20% group: "Is this really a cohort C or futile situation, where [the intervention] is probably not better than medical management?"

Transcatheter VIV/VIR

The majority of prosthetic heart valves are tissue valves that tend to degenerate and eventually fail over time. Surgical replacement of these valves is associated with significant risks.

Transcatheter valve-in-valve/valve-in-ring (VIV/VIR) implantation within a failed bioprosthesis performed in the mitral position has been reported in only small case series, with the safety and efficacy of the technique being largely unknown. The Global Valve-in-Valve Registry, with 765 patients from 73 centers worldwide, was designed to track the efficacy and safety of this nonsurgical redo in either the aortic or mitral valve position. The registry included 190 patients from 23 centers who underwent percutaneous mitral valve procedures (VIV in 157 patients and VIR in 33).

The mechanism of failure was regurgitation in 37%, stenosis in 25%, and a combination of the two in 38%. Patients were a median of 9 years past their last cardiac surgery and were deemed at high risk, with a mean STS score of 14.4. The mean age was 73.6 years, and 65.2% were female. The median length of hospital stay was 8 days.

A SAPIEN or SAPIEN XT device was used in the majority of cases (93.7%), mostly deployed via transapical access (84.7%).

During the procedure, initial device malpositioning occurred in 5.3% of cases, with a second device implanted in 4.3%. Postimplantation valvuloplasty was utilized in 8%.

"We saw a high rate of malpositioning," Dr. Dvir said. "In some of the cases, this led to a decision to leave the malpositioned device in the left atrium and implant a second device."

The incidence of all-cause death at 30 days was 8.9%, with cardiovascular death seen in 6.8% and major stroke in 2.2%. Importantly, 85.8% of patients were in NYHA function class I or II at 30 days, Dr. Dvir said.

"We were very happy to see this," he commented. "If you survive the valve-in-valve or valve-in-ring procedure, you will most likely have a good functional class.

Overall, the Kaplan-Meier mortality rate was 22.3% at 1 year. When stratified according to STS score, however, mortality in the group of patients with an STS score greater than 20% was 45.6%, falling to 23.2% for an STS score of 10%-20% and 12.9% for an STS score less than 10%. Predictors of 1-year mortality included STS score and renal failure.

"In these patients with STS greater than 20%, there is really a big problem. We need to understand which patients should not undergo a procedure, and maybe should be treated with an alternative approach," Dr. Dvir said. He noted that 28% of cases in the registry were in this highest-risk category.

"An 8.9% mortality at 1 year is not so bad in a group with a mean STS score of 14.1," noted Dr. Bavaria. "[But] this is not really a benign procedure as the length of stay was over 8 days."

Surgical valve sizing gone wrong?

After the VIV/VIR procedure, the mean mitral valve area was 2.1 ± 0.7 cm², with a mean residual gradient of 6.2 mm Hg. Significant mitral regurgitation was noted in 4.2% of patients, and a left ventricular outflow tract mean gradient greater than 20 mm Hg was noted in only 2.1% of cases.

"We saw a trend for elevated gradients especially when we were treating small valves with a valve-in-valve approach," Dr. Dvir said.

Indeed, in the patients with smaller surgical valve label size, one-third had postprocedural mean gradients greater than 10 mm Hg. The rates of mean gradient greater than 10 mm Hg dropped to 7.4% and 5.3% with progressively larger surgical valve label sizes.

"I am very worried about the cardiac surgery and interventional cardiology decision-making process, as over 60% of valve-in-ring cases were 26-mm and 28-mm rings and over 56% of valve-in-valve cases were less than or equal to 27-mm prosthetic valves," said Dr. Bavaria. "There will obviously be significant mitral gradients in these cases, as this study showed. Is this simply a lack of knowledge in the operators, should these small valve-in-valve cases be done, or is this a limit of this technology?"

"I think this issue of residual gradients will haunt valve in valve for many years to come," said Dr. Dvir. "However, we know from the aortic arena, that even if you have a high residual gradient, the results at 1 year are not different than the other groups. So, it doesn’t affect 1-year outcomes, although I predict that it will affect the durability of the device and the long-term outcome."

TORONTO – Transcatheter mitral valve-in-valve/valve-in-ring implantation is an effective option in most patients with degenerative mitral valves after surgical intervention, according to Dr. Danny Dvir.

In the highest-risk patients (STS scores greater than 20%), however, mortality after this percutaneous technique approached 50% at 1 year, Dr. Dvir reported at the American Association for Thoracic Surgery annual meeting.

"Most of these procedures were clinically effective, with 1-year results that are comparable to native aortic valve transcatheter implantation," said Dr. Dvir of St. Paul’s Hospital, Vancouver, B.C.

"However, we saw safety and efficacy concerns that included relatively high in-hospital mortality, device malposition, sporadic cases with elevated LVOT [left ventricular outflow tract] gradient, and elevated postprocedural gradients in procedures performed inside small surgical valves."

Dr. Joseph E. Bavaria, professor of surgery and director of the thoracic aortic surgery program at the University of Pennsylvania Health System, Philadelphia, the scheduled discussant of the abstract, asked, referring to the STS score greater than 20% group: "Is this really a cohort C or futile situation, where [the intervention] is probably not better than medical management?"

Transcatheter VIV/VIR

The majority of prosthetic heart valves are tissue valves that tend to degenerate and eventually fail over time. Surgical replacement of these valves is associated with significant risks.

Transcatheter valve-in-valve/valve-in-ring (VIV/VIR) implantation within a failed bioprosthesis performed in the mitral position has been reported in only small case series, with the safety and efficacy of the technique being largely unknown. The Global Valve-in-Valve Registry, with 765 patients from 73 centers worldwide, was designed to track the efficacy and safety of this nonsurgical redo in either the aortic or mitral valve position. The registry included 190 patients from 23 centers who underwent percutaneous mitral valve procedures (VIV in 157 patients and VIR in 33).

The mechanism of failure was regurgitation in 37%, stenosis in 25%, and a combination of the two in 38%. Patients were a median of 9 years past their last cardiac surgery and were deemed at high risk, with a mean STS score of 14.4. The mean age was 73.6 years, and 65.2% were female. The median length of hospital stay was 8 days.

A SAPIEN or SAPIEN XT device was used in the majority of cases (93.7%), mostly deployed via transapical access (84.7%).

During the procedure, initial device malpositioning occurred in 5.3% of cases, with a second device implanted in 4.3%. Postimplantation valvuloplasty was utilized in 8%.

"We saw a high rate of malpositioning," Dr. Dvir said. "In some of the cases, this led to a decision to leave the malpositioned device in the left atrium and implant a second device."

The incidence of all-cause death at 30 days was 8.9%, with cardiovascular death seen in 6.8% and major stroke in 2.2%. Importantly, 85.8% of patients were in NYHA function class I or II at 30 days, Dr. Dvir said.

"We were very happy to see this," he commented. "If you survive the valve-in-valve or valve-in-ring procedure, you will most likely have a good functional class.

Overall, the Kaplan-Meier mortality rate was 22.3% at 1 year. When stratified according to STS score, however, mortality in the group of patients with an STS score greater than 20% was 45.6%, falling to 23.2% for an STS score of 10%-20% and 12.9% for an STS score less than 10%. Predictors of 1-year mortality included STS score and renal failure.

"In these patients with STS greater than 20%, there is really a big problem. We need to understand which patients should not undergo a procedure, and maybe should be treated with an alternative approach," Dr. Dvir said. He noted that 28% of cases in the registry were in this highest-risk category.

"An 8.9% mortality at 1 year is not so bad in a group with a mean STS score of 14.1," noted Dr. Bavaria. "[But] this is not really a benign procedure as the length of stay was over 8 days."

Surgical valve sizing gone wrong?

After the VIV/VIR procedure, the mean mitral valve area was 2.1 ± 0.7 cm², with a mean residual gradient of 6.2 mm Hg. Significant mitral regurgitation was noted in 4.2% of patients, and a left ventricular outflow tract mean gradient greater than 20 mm Hg was noted in only 2.1% of cases.

"We saw a trend for elevated gradients especially when we were treating small valves with a valve-in-valve approach," Dr. Dvir said.

Indeed, in the patients with smaller surgical valve label size, one-third had postprocedural mean gradients greater than 10 mm Hg. The rates of mean gradient greater than 10 mm Hg dropped to 7.4% and 5.3% with progressively larger surgical valve label sizes.

"I am very worried about the cardiac surgery and interventional cardiology decision-making process, as over 60% of valve-in-ring cases were 26-mm and 28-mm rings and over 56% of valve-in-valve cases were less than or equal to 27-mm prosthetic valves," said Dr. Bavaria. "There will obviously be significant mitral gradients in these cases, as this study showed. Is this simply a lack of knowledge in the operators, should these small valve-in-valve cases be done, or is this a limit of this technology?"

"I think this issue of residual gradients will haunt valve in valve for many years to come," said Dr. Dvir. "However, we know from the aortic arena, that even if you have a high residual gradient, the results at 1 year are not different than the other groups. So, it doesn’t affect 1-year outcomes, although I predict that it will affect the durability of the device and the long-term outcome."