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Four-year experience with the Toronto stentless porcine valve
Asia Pacific
Heart
J 1999;8( 1)
Abstracts Of The Cardiothoracic Section 13th Inter Annual Scientijk Congress, RACS
thereafter at a higher rate to further reduce CO by 10%. Haemodynamic and echocardiographic parameters were monitored at surgery and termination of pacing. Results: At termination of pacing, significant findings were improvement in left ventricular fractional shortening (p=O.O07), lower mitral regurgitation (p=O.O06), smaller left ventricular long-axis area (p=O.Ol) and better contractility measured by [dp/dt]/P (p=O.O08), in the wrap group. Animals were euthanased at 6 to 13 weeks after jacket implantation. Histopathology revealed no
significant reaction to the jacket except for mild adhesions and no constriction of epicardial coronary arteries. Conclusions: Passive ventricular containment reduced the deleterious consequences of dilated cardiomyopathy in this animal model of progressive heart failure. The implanted polyester jacket was well tolerated and mildly adherent to the epicardium. This device may have therapeutic application in patients with progressive DCM.
The Toronto StentlessPorcine Valve In 100 Consecutive Elderly Patients Allan Hilless, Gregory Scalia, Andrew Simpson, Stewart Dann Wesley Hospital, Brisbane, Queensland
Background:
The development of stentless xenograft aortic valves has provided low profile devices with excellent haemodynamics and no requirement for anticoagulants. These characteristics make such replacement devices highly desirable in elderly patients. It has been our policy to offer the Toronto Stentless Porcine Valve to all such patients. Methods: In the period from April 1996,100 consecutive patients referred for aortic valve replacement underwent stentless valve implantation. No referred patient was refused surgery in this period. Results: These elderly patients (74*8 years; range, 60-90 years) were highly symptomatic at referral: 85 were NYHA IV, and 15 were NYHA III. The majority had significant coronary artery disease (65%), and all underwent simultaneous CABG. The referral disease was stenotic in 95 patients and regurgitant in 5. The majority of cases represented degenerative aortic valve disease. The instance of associated non-cardiac disease was
COAD 15%, renal failure 9%, and diabetes 7%. Bypass time for the entire group was 109+23 min with a mean clamp time of 83*16 min. Clamp time for aortic valve replacement was 5OklO min. The valve size ranged from 19-29 mm with the most common valve size being 25 mm. Only 6 patients required inotropic support in the postoperative period. There were 3 perioperative deaths. At follow-up echocardiography, left ventricular function was normal in all patients. In patients followed for more than 12 months, there was a significant reduction in left ventricular mass. The prosthetic haemodynamics were excellent with mean forward gradients of 1224 mmHg. Conclusions: The Toronto Stentless Porcine Xenograft can be safely implanted in severely symptomatic elderly patients with end-stage aortic valve disease. At follow-up these prostheses had excellent flow characteristics and patients enjoy significant improvement in functional status. Long-term evaluation of these patients continues.
Four-year Experience With The Toronto StentlessPorcine Valve P. Skillington Royal Melbourne Hospital, Melbourne, Victoria
Background:
Since June, 1994,43 consecutive patients have undergone AVR using the Toronto SPV with no early mortality. Results: Mean age was 75 years (range, 67-87); 26 females and 17 males. The major indication for surgery was aortic stenosis in 98%, with additional procedures in 27 (61%) including: CABG in 21 (49%); procedure on aorta in 10 (23%); and LV myomectomy in 6 (13%). Aortic cross-clamp times: AVR, 109 min; AVR and associated procedure, 137 min. Significant early complications occurred in 3 patients. Intra-aortic balloon pump support was required in 2 patients, and atria1 arrhythmia occurred in 20 patients (46%). 100% followup was at mean interval of 23.2 months. There was 1 late
death (not cardiac), and TIA in 2 patients, There was warfarin treatment in 3 patients (2 with chronic AF). The majority were NYHA I actuarial survival 100% at 1 year, and 95% at 2 years. There were no reoperations. Echo analysis: Detailed analysis of initial 34 patients, all with at least 12 months of follow-up is available. Aortic valve gradients reduce from mean of 11 mmHg at 1 week to 8 mmHg at 602. Late gradient for valve size 22 was 13.6 mmHg, while for other sizes (23-29) was 6.7 mmHg. Aortic regurgitation was nil or trivial in 32 (94%), mild in 1 (3%), and moderate in 1 (3%). The demonstrated reduction in LV wall thickness from preoperative to last postoperative study was 1.27 cm to 0.99 cm. despite 23
64
Asia Pacific
Heart J 1999;8(1)
Abstracts
Of The Cardiothoracic
Section
13th Inter Annual Scientific Congress, RACS
patients (67%) remaining on treatment for hypertension. Conclusions: Despite long cross-clamp times to insert a Toronto SPV, in a group of elderly patients with aortic stenosis and left ventricular hypertrophy, and with more
than half having mortality and echocardiography and resolution of
additional CABG, there was no early no late cardiac mortality, with revealing low postoperative gradients LVH.
The Cryolife”-O’Brien Composite Stentless Aortic Porcine Xenograft in 240 Patients M.F. O’Brien,12 M.A.H
Gardner,*,2 R.B. Garlick,’ A. Cochranel
1The Prince Charles Hospital, 2 St Andrew’s War Memorial Hospital, Brisbane, Queensland
Background:
This analysis of the fate and function of 240 elderly patients receiving the Cryolifer”-O’Brien stentless xenograft for AVR is to determine if this valve is an ideal device for the elderly patient. Methods: This composite stentless xenograft - assembled from 3 separate glutaraldehyde preserved non-coronary porcine aortic valve leaflets - has minimal xenograft aortic wall, no need for dacron support and is therefore truly stentless. The valve is implanted supra-annularly with a single continuous suture line, providing a short CPB time for an elderly patient cohort, almost half of whom have required concomitant CABG. 240 patients (mean age 73 years, females 45%) underwent AVR, with 45% requiring CABG (mean, 2 5 grafts), from December 1992 to September 1998. The 100% patient follow-up has included serial echocardiographic postoperative assessments at 6 months, 12 months and thereafter yearly. Survival and freedom from morbid events depict patient and valve performance. Results: Of the 240
patients, there were 3 hospital or 30-day deaths (1.3%). Accepting this population as elderly, there have been so far 11 late deaths (1.5 months to 5 years postoperative, mean, 2 years 3 months): CVA (5), renal failure (2), endocarditis (l), lymphoma (l), mesenteric infarction (1) and myocardial infarction (1). Early thromboembolism has occurred only in patients (4) in atria1 fibrillation without anticoagulants. Anticoagulation, formerly not routine, is now given for 2 months. There has been no valve failure, no progression of incompetence, and 1 explant for endocarditis. Two patients have required successful reoperation for closure of periprosthetic leak without explant. Serial echocardiography has demonstrated low valve gradients (mean 8.3 mmHg), zero or a trace of incompetence in most patients. Conclusions: This type of stentless xenograft in this elderly patient cohort has provided a safe, effective replacement device over 6 years. It is considered an ideal valve for most elderly patients requiring AVR.
AssessmentOf The ATS Mechanical Prosthesis In 246 Consecutive Implants T. Fayers, P. Tesar, M. O’Brien, G. Stafford, P. Pohlner, T. Mau, R. Tam, H. Jalali The Prince Charles Hospital, Brisbane, Queensland
Background:
The ATS mechanical valve represents the second generation of bileaflet prostheses. Its open pivot design confers a potential significant advantage, the altered washing reducing thrombotic and thromboembolic risk. The utility of this new prosthesis was assessed in the intermediate term. Methods: Between May 1994 and June 1998, 230 patients had implanted 246 ATS mechanical valves: 164 isolated aortic, 48 isolated mitral, 16 combined aortic-mitral and 2 tricuspid. Median patient age was 60 years (range, 4 months-83 years). Data entry has been preoperatively, at discharge, at 6 weeks, 6 months, 12 months and thereafter annually, or with morbidity or mortality. Clinical outcomes and the echocardiographic results have been assessed. Results: Nine patients died, 2 early (1 inhospital) and 7 late. Of 220 patients available for followup at 6 weeks postoperatively, 200 were in NYHA class status I, 18 status II, 2 status III (preoperatively, 156 NYHA class status Ill - IV). Follow-up has been
prospective and complete; accrued is 485 years of follow-up. The incidences of valve-related complications have been: thromboembolism (presumed) 13, haemorrhage 4, thrombosis 0, prosthetic valve endocarditis 4, paravalvar leak 5, haemolysis 1, and valve reoperation 1. In patients with significant aortic stenosis following aortic valve replacement, echocardiographic assessment has shown surprisingly good left ventricular mass regression, equivalent to that seen in a stentless xenograft with a similiar aortic valve annular diameter. Conclusions: The ATS mechanical valve has been, in our practice, satisfactory. It is user friendly for the surgeon, implantation being associated with an extremely low perioperative mortality and a consistent patient outcome. The haemodynamics are satisfactory, and in aortic stenosis, left ventricular mass regression has reflected this. These features have translated to marked improvement in the patients’ clinical status postoperatively.
65
Heart
J 1999;8( 1)
Abstracts Of The Cardiothoracic Section 13th Inter Annual Scientijk Congress, RACS
thereafter at a higher rate to further reduce CO by 10%. Haemodynamic and echocardiographic parameters were monitored at surgery and termination of pacing. Results: At termination of pacing, significant findings were improvement in left ventricular fractional shortening (p=O.O07), lower mitral regurgitation (p=O.O06), smaller left ventricular long-axis area (p=O.Ol) and better contractility measured by [dp/dt]/P (p=O.O08), in the wrap group. Animals were euthanased at 6 to 13 weeks after jacket implantation. Histopathology revealed no
significant reaction to the jacket except for mild adhesions and no constriction of epicardial coronary arteries. Conclusions: Passive ventricular containment reduced the deleterious consequences of dilated cardiomyopathy in this animal model of progressive heart failure. The implanted polyester jacket was well tolerated and mildly adherent to the epicardium. This device may have therapeutic application in patients with progressive DCM.
The Toronto StentlessPorcine Valve In 100 Consecutive Elderly Patients Allan Hilless, Gregory Scalia, Andrew Simpson, Stewart Dann Wesley Hospital, Brisbane, Queensland
Background:
The development of stentless xenograft aortic valves has provided low profile devices with excellent haemodynamics and no requirement for anticoagulants. These characteristics make such replacement devices highly desirable in elderly patients. It has been our policy to offer the Toronto Stentless Porcine Valve to all such patients. Methods: In the period from April 1996,100 consecutive patients referred for aortic valve replacement underwent stentless valve implantation. No referred patient was refused surgery in this period. Results: These elderly patients (74*8 years; range, 60-90 years) were highly symptomatic at referral: 85 were NYHA IV, and 15 were NYHA III. The majority had significant coronary artery disease (65%), and all underwent simultaneous CABG. The referral disease was stenotic in 95 patients and regurgitant in 5. The majority of cases represented degenerative aortic valve disease. The instance of associated non-cardiac disease was
COAD 15%, renal failure 9%, and diabetes 7%. Bypass time for the entire group was 109+23 min with a mean clamp time of 83*16 min. Clamp time for aortic valve replacement was 5OklO min. The valve size ranged from 19-29 mm with the most common valve size being 25 mm. Only 6 patients required inotropic support in the postoperative period. There were 3 perioperative deaths. At follow-up echocardiography, left ventricular function was normal in all patients. In patients followed for more than 12 months, there was a significant reduction in left ventricular mass. The prosthetic haemodynamics were excellent with mean forward gradients of 1224 mmHg. Conclusions: The Toronto Stentless Porcine Xenograft can be safely implanted in severely symptomatic elderly patients with end-stage aortic valve disease. At follow-up these prostheses had excellent flow characteristics and patients enjoy significant improvement in functional status. Long-term evaluation of these patients continues.
Four-year Experience With The Toronto StentlessPorcine Valve P. Skillington Royal Melbourne Hospital, Melbourne, Victoria
Background:
Since June, 1994,43 consecutive patients have undergone AVR using the Toronto SPV with no early mortality. Results: Mean age was 75 years (range, 67-87); 26 females and 17 males. The major indication for surgery was aortic stenosis in 98%, with additional procedures in 27 (61%) including: CABG in 21 (49%); procedure on aorta in 10 (23%); and LV myomectomy in 6 (13%). Aortic cross-clamp times: AVR, 109 min; AVR and associated procedure, 137 min. Significant early complications occurred in 3 patients. Intra-aortic balloon pump support was required in 2 patients, and atria1 arrhythmia occurred in 20 patients (46%). 100% followup was at mean interval of 23.2 months. There was 1 late
death (not cardiac), and TIA in 2 patients, There was warfarin treatment in 3 patients (2 with chronic AF). The majority were NYHA I actuarial survival 100% at 1 year, and 95% at 2 years. There were no reoperations. Echo analysis: Detailed analysis of initial 34 patients, all with at least 12 months of follow-up is available. Aortic valve gradients reduce from mean of 11 mmHg at 1 week to 8 mmHg at 602. Late gradient for valve size 22 was 13.6 mmHg, while for other sizes (23-29) was 6.7 mmHg. Aortic regurgitation was nil or trivial in 32 (94%), mild in 1 (3%), and moderate in 1 (3%). The demonstrated reduction in LV wall thickness from preoperative to last postoperative study was 1.27 cm to 0.99 cm. despite 23
64
Asia Pacific
Heart J 1999;8(1)
Abstracts
Of The Cardiothoracic
Section
13th Inter Annual Scientific Congress, RACS
patients (67%) remaining on treatment for hypertension. Conclusions: Despite long cross-clamp times to insert a Toronto SPV, in a group of elderly patients with aortic stenosis and left ventricular hypertrophy, and with more
than half having mortality and echocardiography and resolution of
additional CABG, there was no early no late cardiac mortality, with revealing low postoperative gradients LVH.
The Cryolife”-O’Brien Composite Stentless Aortic Porcine Xenograft in 240 Patients M.F. O’Brien,12 M.A.H
Gardner,*,2 R.B. Garlick,’ A. Cochranel
1The Prince Charles Hospital, 2 St Andrew’s War Memorial Hospital, Brisbane, Queensland
Background:
This analysis of the fate and function of 240 elderly patients receiving the Cryolifer”-O’Brien stentless xenograft for AVR is to determine if this valve is an ideal device for the elderly patient. Methods: This composite stentless xenograft - assembled from 3 separate glutaraldehyde preserved non-coronary porcine aortic valve leaflets - has minimal xenograft aortic wall, no need for dacron support and is therefore truly stentless. The valve is implanted supra-annularly with a single continuous suture line, providing a short CPB time for an elderly patient cohort, almost half of whom have required concomitant CABG. 240 patients (mean age 73 years, females 45%) underwent AVR, with 45% requiring CABG (mean, 2 5 grafts), from December 1992 to September 1998. The 100% patient follow-up has included serial echocardiographic postoperative assessments at 6 months, 12 months and thereafter yearly. Survival and freedom from morbid events depict patient and valve performance. Results: Of the 240
patients, there were 3 hospital or 30-day deaths (1.3%). Accepting this population as elderly, there have been so far 11 late deaths (1.5 months to 5 years postoperative, mean, 2 years 3 months): CVA (5), renal failure (2), endocarditis (l), lymphoma (l), mesenteric infarction (1) and myocardial infarction (1). Early thromboembolism has occurred only in patients (4) in atria1 fibrillation without anticoagulants. Anticoagulation, formerly not routine, is now given for 2 months. There has been no valve failure, no progression of incompetence, and 1 explant for endocarditis. Two patients have required successful reoperation for closure of periprosthetic leak without explant. Serial echocardiography has demonstrated low valve gradients (mean 8.3 mmHg), zero or a trace of incompetence in most patients. Conclusions: This type of stentless xenograft in this elderly patient cohort has provided a safe, effective replacement device over 6 years. It is considered an ideal valve for most elderly patients requiring AVR.
AssessmentOf The ATS Mechanical Prosthesis In 246 Consecutive Implants T. Fayers, P. Tesar, M. O’Brien, G. Stafford, P. Pohlner, T. Mau, R. Tam, H. Jalali The Prince Charles Hospital, Brisbane, Queensland
Background:
The ATS mechanical valve represents the second generation of bileaflet prostheses. Its open pivot design confers a potential significant advantage, the altered washing reducing thrombotic and thromboembolic risk. The utility of this new prosthesis was assessed in the intermediate term. Methods: Between May 1994 and June 1998, 230 patients had implanted 246 ATS mechanical valves: 164 isolated aortic, 48 isolated mitral, 16 combined aortic-mitral and 2 tricuspid. Median patient age was 60 years (range, 4 months-83 years). Data entry has been preoperatively, at discharge, at 6 weeks, 6 months, 12 months and thereafter annually, or with morbidity or mortality. Clinical outcomes and the echocardiographic results have been assessed. Results: Nine patients died, 2 early (1 inhospital) and 7 late. Of 220 patients available for followup at 6 weeks postoperatively, 200 were in NYHA class status I, 18 status II, 2 status III (preoperatively, 156 NYHA class status Ill - IV). Follow-up has been
prospective and complete; accrued is 485 years of follow-up. The incidences of valve-related complications have been: thromboembolism (presumed) 13, haemorrhage 4, thrombosis 0, prosthetic valve endocarditis 4, paravalvar leak 5, haemolysis 1, and valve reoperation 1. In patients with significant aortic stenosis following aortic valve replacement, echocardiographic assessment has shown surprisingly good left ventricular mass regression, equivalent to that seen in a stentless xenograft with a similiar aortic valve annular diameter. Conclusions: The ATS mechanical valve has been, in our practice, satisfactory. It is user friendly for the surgeon, implantation being associated with an extremely low perioperative mortality and a consistent patient outcome. The haemodynamics are satisfactory, and in aortic stenosis, left ventricular mass regression has reflected this. These features have translated to marked improvement in the patients’ clinical status postoperatively.
65