JACC Vat . 14 . No . 6 May 1492 : 116S-70
1314;
LETTERS TO THE EDITOR Worldwide Call for Patients With the Bjork . Shiley Convexo-Concave Heart Valve I"he purpose of Ibis lever is to into rm you about an effort to notify people worldwide with the Bjork-Shilcy Convexo-Concave heart valve of a class action lawsuit in Cincinnati, Ohio . The name of the lawsuit is Bott lige . elm. I . S6ilrv Inrruyarnted and i".1rerJJ,'. Case No. C-1-91-25(,, which is pending before Judge S . Arthur Spiegel of the United State, District Court for the Southern District of Ohio. ,".ccip; .o;,nf ;Lc--;- ul ice„yousvs .achcalga,kediudccidc whether they want babe part of the class action . Pfizer Inc and Shiley incorporated recently announced thin they had entered into a class action acttlemeat agreement involving recipients of the Bjork-Shilcy 60 and 7(1 degree Convexo-Concave heart valve . as wc11 as the spou -of those recipients- This agreement gun, antees benefits to recipients with functioning valves, including payments from a fund of $80 million or more, depending on the number ofelaimants .that canheused fortinypurpos including consulunion with a cardiologist or other health care provider . the settlement also provides for additional vuPne research and ether benefits . Should the valve ever haaire, recipients would be promptly compensated according to a court-approved settlement futmula . Valve recipients will he hound by the terms of the settlement, if approve,] . uuicss they specifically exclude t hemselves . i n writing . from the lawsuii.'1'hmeffe . it is important that informalion about the settlement he provided to these people and their spouses . The Court has begun a process to notify recipients and their spouses worldwide about this agree ent and how they can respond . By May 22, 1992, all Bjork-Shilcy Convexo-Concave valve recipients are requested to write : Stanley M . Cheslcy . Esq . Waite. Schneider . Baylew & Chesley Co . . L.P .A . 1513 Central Trust lower Cincinnati . Ohio 45202 FAX : 15171621-0162 DANIELJ . LYONS . JR . IApun' (lrrk Unia•J 51nno Moon Cuurr SuuthmnUi, 1A if ON, B'eamra I irisena
cainamide wrs infused at a me, of 12 to IS mglkg body weight, which is certainly a therapeutic dose . whereas propafenone was give e dose of up to I to 2 mglkg over 1(1 min . It has already hear demonstrated (3) that propafenone requires a relatively longtime to bind to the myocardium. Thus . considering also the very rapid decrease in plasma concentration and the rather large distribution volume (4), to obtain the best effects the intravenous bolus dose must be followed by :I maintenance infusion of at least (1007 I„ (1.1114 mgrkg per min 15) . -,c,l studies underline the importance of propafenone infusion~after an intravenous bolus. In the study of Shen et al . (6) noninducibility of sustained ventricular tachycandin was obtained much more frequently by a 2 iug/min propafenone {nfusioa, aftc a 7 mg/kg propafenone bolus dose, than by a I mglmin infusion . In the _ study of Doherty et .d . (71 the dose of propafenone was increased from I to 2 mg/kg and a constant infusion was added because induction of ventricular tachycerdia was not prevented in any of the first 10 patients submitted to electrophysiologic evaluation . In that study the overall efficacy of intravenous propafenone was very low ; however . a comparison of different doses is not reported . Our view, as demonstrated previously (5,81, is that intravenously administered propafenone has to be infused with a maintenance dose and this concept has become almost a rule in our country . The main consequence of these brief considerations is that protocols involving intravenously administered propafenone and including only an acute bolus dose should not he considered because they underestimate the therapeutic efficacy ofthe drug . It is obvious that more attention given to European scientific publications would contribute to avoiding confusion and mistakes with respect to anliarrhyihmic drugs . ALESSANDRO C APUCCI. M D CIUSEPPE BORIANI . M D Irrrtfarte ul'Cordtssm'arcrdnr 9/tistnsr !)air -,I, uiBiloeuu I'ed klrae .rang ar0 .1N. Rnluenu, lady References
I
Intravenous Administration of Propafenone As European cardiologists whose practice is devoted largely to arrhvthmias and amino rhythmic drug smdirsi we must comment on the article of Boahene et al . (I I on the effects of propafenone and procainamide on ;trial fibrillation in the Wolf'-Parkinson-White syndrome . This well designed and very nicely presented paper compares the electrophysiulogic effects of the two intravenously infused drugs on RR intervals and their capacity to terminate xtriel fibrillation . One of the conclusions is that in these patients procainamide terminated atriol fibrillation more frequently than did prop:Bennne Even Jordaens and Clemcat (2) found procainamide more effective than pnrp'allcrene in preventing inducibility of sustained ventricular mchycandla . The problem is that in these studies pro- 1
b, the Amcrman l nliegc al Unliulngt
L Rauhcne Ka . Kieiu li) . W, R . 5harmn An. Fsiimuo 0. Tern,ircnion al-I,In I Iihrillunan is the ab/R-pates' n-while s,adrome by nrtis .enamede and pieputtupna' is panuna< ur,.vial fihraunori' cc'/, lc'nfah, J Am WE Cmainl I M .16:1 WS-Ia . 2.JOruacmiJ.C'Ienxnt01 .Cempari nufprominamiieandnwnateneneinveninomar nah. . ..dia Iahsln PACT /9G7dn'622 . 1 Cnlli, Ay . Kate, RE. \tyncrrdi :l aplaka kinetici and nhmmumJynwmcs of pro . Internee in the is,d :ue,i petuntO mhhh heart . I Phutnu :ul Esp Ther 1955 217 :715-C . 4. Cannphl S. Lehsu;k C. wink/, RA. Ranimn DC tams RE Pru,safic,- :,pi .1k, in a;vaixc urhy,hmia . run starmuaul then isson6dn H. , t. Cup-, A. lint ani G . hlarchesini H . e1 al. M1llnimal u/Ste aus cnnnmm,u,n .slues of pn,pm'cn .,ad sJwan, ppronarenom In uama anal ehmma mer.,pt . (:stir.,„ nmg. Tb .r I44ta^RI-7 r I, . Shin EN . Sung RI . Numdl F . al xlA rlen,nph)siohnic and hensvrnundc trce„ et . ms Pramrcnonc in Isniams with racurrcn, .an,ricular iechuamd,a.I Am Ct1I ("din 14 .1:1 :41-7 . 7 . umenu lo . w,wm,n RI. . sienrle 740.-j . una4-d r ae .,r,v,.en,m, r,np,ren.,ne hyJ'eA/s'tdainIhcl rnaofsudnineJs,aariau1 .rc,ho,,uJ,a!elntmphysiaMgic elt:al and rash, of prnirummau ,anvicuhn aimulutum . l inn let fmdiol Ima:a, s.
iisu,ci A . Gnhate S . emmi G . Fulham I . sfugnam a . Curd--- rarnw:,e„gia_ 1 . nFnlh¢nne :nri.dv
di n r•n j,,-nun G Rat aaai,d 1%7 :1 -97n_st. 07311 .7 ses5. 0
1314;
LETTERS TO THE EDITOR Worldwide Call for Patients With the Bjork . Shiley Convexo-Concave Heart Valve I"he purpose of Ibis lever is to into rm you about an effort to notify people worldwide with the Bjork-Shilcy Convexo-Concave heart valve of a class action lawsuit in Cincinnati, Ohio . The name of the lawsuit is Bott lige . elm. I . S6ilrv Inrruyarnted and i".1rerJJ,'. Case No. C-1-91-25(,, which is pending before Judge S . Arthur Spiegel of the United State, District Court for the Southern District of Ohio. ,".ccip; .o;,nf ;Lc--;- ul ice„yousvs .achcalga,kediudccidc whether they want babe part of the class action . Pfizer Inc and Shiley incorporated recently announced thin they had entered into a class action acttlemeat agreement involving recipients of the Bjork-Shilcy 60 and 7(1 degree Convexo-Concave heart valve . as wc11 as the spou -of those recipients- This agreement gun, antees benefits to recipients with functioning valves, including payments from a fund of $80 million or more, depending on the number ofelaimants .that canheused fortinypurpos including consulunion with a cardiologist or other health care provider . the settlement also provides for additional vuPne research and ether benefits . Should the valve ever haaire, recipients would be promptly compensated according to a court-approved settlement futmula . Valve recipients will he hound by the terms of the settlement, if approve,] . uuicss they specifically exclude t hemselves . i n writing . from the lawsuii.'1'hmeffe . it is important that informalion about the settlement he provided to these people and their spouses . The Court has begun a process to notify recipients and their spouses worldwide about this agree ent and how they can respond . By May 22, 1992, all Bjork-Shilcy Convexo-Concave valve recipients are requested to write : Stanley M . Cheslcy . Esq . Waite. Schneider . Baylew & Chesley Co . . L.P .A . 1513 Central Trust lower Cincinnati . Ohio 45202 FAX : 15171621-0162 DANIELJ . LYONS . JR . IApun' (lrrk Unia•J 51nno Moon Cuurr SuuthmnUi, 1A if ON, B'eamra I irisena
cainamide wrs infused at a me, of 12 to IS mglkg body weight, which is certainly a therapeutic dose . whereas propafenone was give e dose of up to I to 2 mglkg over 1(1 min . It has already hear demonstrated (3) that propafenone requires a relatively longtime to bind to the myocardium. Thus . considering also the very rapid decrease in plasma concentration and the rather large distribution volume (4), to obtain the best effects the intravenous bolus dose must be followed by :I maintenance infusion of at least (1007 I„ (1.1114 mgrkg per min 15) . -,c,l studies underline the importance of propafenone infusion~after an intravenous bolus. In the study of Shen et al . (6) noninducibility of sustained ventricular tachycandin was obtained much more frequently by a 2 iug/min propafenone {nfusioa, aftc a 7 mg/kg propafenone bolus dose, than by a I mglmin infusion . In the _ study of Doherty et .d . (71 the dose of propafenone was increased from I to 2 mg/kg and a constant infusion was added because induction of ventricular tachycerdia was not prevented in any of the first 10 patients submitted to electrophysiologic evaluation . In that study the overall efficacy of intravenous propafenone was very low ; however . a comparison of different doses is not reported . Our view, as demonstrated previously (5,81, is that intravenously administered propafenone has to be infused with a maintenance dose and this concept has become almost a rule in our country . The main consequence of these brief considerations is that protocols involving intravenously administered propafenone and including only an acute bolus dose should not he considered because they underestimate the therapeutic efficacy ofthe drug . It is obvious that more attention given to European scientific publications would contribute to avoiding confusion and mistakes with respect to anliarrhyihmic drugs . ALESSANDRO C APUCCI. M D CIUSEPPE BORIANI . M D Irrrtfarte ul'Cordtssm'arcrdnr 9/tistnsr !)air -,I, uiBiloeuu I'ed klrae .rang ar0 .1N. Rnluenu, lady References
I
Intravenous Administration of Propafenone As European cardiologists whose practice is devoted largely to arrhvthmias and amino rhythmic drug smdirsi we must comment on the article of Boahene et al . (I I on the effects of propafenone and procainamide on ;trial fibrillation in the Wolf'-Parkinson-White syndrome . This well designed and very nicely presented paper compares the electrophysiulogic effects of the two intravenously infused drugs on RR intervals and their capacity to terminate xtriel fibrillation . One of the conclusions is that in these patients procainamide terminated atriol fibrillation more frequently than did prop:Bennne Even Jordaens and Clemcat (2) found procainamide more effective than pnrp'allcrene in preventing inducibility of sustained ventricular mchycandla . The problem is that in these studies pro- 1
b, the Amcrman l nliegc al Unliulngt
L Rauhcne Ka . Kieiu li) . W, R . 5harmn An. Fsiimuo 0. Tern,ircnion al-I,In I Iihrillunan is the ab/R-pates' n-while s,adrome by nrtis .enamede and pieputtupna' is panuna< ur,.vial fihraunori' cc'/, lc'nfah, J Am WE Cmainl I M .16:1 WS-Ia . 2.JOruacmiJ.C'Ienxnt01 .Cempari nufprominamiieandnwnateneneinveninomar nah. . ..dia Iahsln PACT /9G7dn'622 . 1 Cnlli, Ay . Kate, RE. \tyncrrdi :l aplaka kinetici and nhmmumJynwmcs of pro . Internee in the is,d :ue,i petuntO mhhh heart . I Phutnu :ul Esp Ther 1955 217 :715-C . 4. Cannphl S. Lehsu;k C. wink/, RA. Ranimn DC tams RE Pru,safic,- :,pi .1k, in a;vaixc urhy,hmia . run starmuaul then isson6dn H. , t. Cup-, A. lint ani G . hlarchesini H . e1 al. M1llnimal u/Ste aus cnnnmm,u,n .slues of pn,pm'cn .,ad sJwan, ppronarenom In uama anal ehmma mer.,pt . (:stir.,„ nmg. Tb .r I44ta^RI-7 r I, . Shin EN . Sung RI . Numdl F . al xlA rlen,nph)siohnic and hensvrnundc trce„ et . ms Pramrcnonc in Isniams with racurrcn, .an,ricular iechuamd,a.I Am Ct1I ("din 14 .1:1 :41-7 . 7 . umenu lo . w,wm,n RI. . sienrle 740.-j . una4-d r ae .,r,v,.en,m, r,np,ren.,ne hyJ'eA/s'tdainIhcl rnaofsudnineJs,aariau1 .rc,ho,,uJ,a!elntmphysiaMgic elt:al and rash, of prnirummau ,anvicuhn aimulutum . l inn let fmdiol Ima:a, s.
iisu,ci A . Gnhate S . emmi G . Fulham I . sfugnam a . Curd--- rarnw:,e„gia_ 1 . nFnlh¢nne :nri.dv
di n r•n j,,-nun G Rat aaai,d 1%7 :1 -97n_st. 07311 .7 ses5. 0
